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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 K112784
Device Name RENASYS AB ABOMINAL DRESSING KIT
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA D REYNOLDS
Correspondent
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA D REYNOLDS
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/26/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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