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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 K946106
FOIA Releasable 510(k) K946106
Device Name GORE-TEX DUALMESH PLUS BIOMATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
elkton,  MD  21922 -1408
Applicant Contact r l pratt
Correspondent
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
elkton,  MD  21922 -1408
Correspondent Contact r l pratt
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/14/1994
Decision Date 04/24/1995
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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