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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 K963619
Device Name GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
Applicant
W.L. Gore & Associates, Inc.
3750 W. Kiltie
Flagstaff,  AZ  86001 -0900
Applicant Contact JOHN W NICHOLSON
Correspondent
W.L. Gore & Associates, Inc.
3750 W. Kiltie
Flagstaff,  AZ  86001 -0900
Correspondent Contact JOHN W NICHOLSON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/10/1996
Decision Date 10/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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