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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 K946267
Device Name GORE-TEX SAM FACIAL IMPLANT
Applicant
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN.
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Applicant Contact THOMAS O'HARA
Correspondent
W.L. GORE & ASSOCIATES,INC
3750 WEST KILTIE LN.
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Correspondent Contact THOMAS O'HARA
Regulation Number878.3550
Classification Product Code
FWP  
Date Received12/23/1994
Decision Date 03/22/1995
Decision Substantially Equivalent (SESE)
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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