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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 K010228
Device Name GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Applicant Contact R. LARRY PRATT
Correspondent
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON,  MD  21922 -1408
Correspondent Contact R. LARRY PRATT
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/24/2001
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
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