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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013 Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

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Page 1: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 2: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 3: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 4: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 5: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 6: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 7: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 8: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 9: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 10: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 11: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 12: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 14: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 15: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 16: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 17: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 18: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 19: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 20: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 21: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 22: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 23: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 24: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 25: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 26: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 27: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 28: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 29: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 30: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 31: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 32: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 33: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 34: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 35: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

Page 36: 4XHVWLRQV&RQWDFW)'$ &'5+ )2,67$786#IGD KKV JRYRU · 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd kkv jryru 5hfrugvsurfhvvhgxqghu)2,$5htxhvw 5hohdvhge\&'5+rq 4xhvwlrqv"&rqwdfw)'$ &'5+ )2,67$786#igd

Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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Records processed under FOIA Request # 2012-1747; Released by CDRH on 03-12-2013

Questions? Contact FDA/CDRH/[email protected] or 301-796-8118

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