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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 K962401
Device Name GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
Applicant
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln.
P.O. Box 900
Flagstaff,  AZ  86002
Applicant Contact R. LARRY PRATT
Correspondent
W. L. Gore & Associates, Inc.
3750 W. Kiltie Ln.
P.O. Box 900
Flagstaff,  AZ  86002
Correspondent Contact R. LARRY PRATT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/21/1996
Decision Date 09/03/1996
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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