GORE-TEX SAM FACIAL IMPLANT

Prosthesis, Chin, Internal

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Sam Facial Implant.

Pre-market Notification Details

Device IDK946267
510k NumberK946267
Device Name:GORE-TEX SAM FACIAL IMPLANT
ClassificationProsthesis, Chin, Internal
Applicant W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff,  AZ  86002 -0900
ContactThomas O'hara
CorrespondentThomas O'hara
W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff,  AZ  86002 -0900
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-23
Decision Date1995-03-22

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