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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K951700
Device Name GORE-TEX SOFT TISSUE PATCH
Applicant
W.L. GORE & ASSOCIATES,INC
3750 WEST KITTIE LN.
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Applicant Contact JOHN W NICHOLSON
Correspondent
W.L. GORE & ASSOCIATES,INC
3750 WEST KITTIE LN.
P.O. BOX 900
FLAGSTAFF,  AZ  86002 -0900
Correspondent Contact JOHN W NICHOLSON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/12/1995
Decision Date 10/07/1995
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
Predetermined Change
Control Plan Authorized		 No
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