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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, chin, internal
510(k) Number K933367
Device Name GORE-TEX FACIAL IMPLANT
Applicant
W.L. GORE & ASSOCIATES,INC
1505 N. FOURTH ST.
P.O. BOX 3000
FLAGSTAFF,  AZ  86003 -3000
Applicant Contact LARRY J KOVACH
Correspondent
W.L. GORE & ASSOCIATES,INC
1505 N. FOURTH ST.
P.O. BOX 3000
FLAGSTAFF,  AZ  86003 -3000
Correspondent Contact LARRY J KOVACH
Regulation Number878.3550
Classification Product Code
FWP  
Subsequent Product Code
LZK  
Date Received07/09/1993
Decision Date 07/28/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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