GORE-TEX 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 Facial Implant.

Pre-market Notification Details

Device IDK933367
510k NumberK933367
Device Name:GORE-TEX FACIAL IMPLANT
ClassificationProsthesis, Chin, Internal
Applicant W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003 -3000
ContactLarry J Kovach
CorrespondentLarry J Kovach
W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff,  AZ  86003 -3000
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-09
Decision Date1994-07-28

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