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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 K100787
FOIA Releasable 510(k) K100787
Device Name RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA D REYNOLDS
Correspondent
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA D REYNOLDS
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/19/2010
Decision Date 09/17/2010
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
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