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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K102001
Device Name MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA REYNOLDS
Correspondent
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA REYNOLDS
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/15/2010
Decision Date 08/06/2010
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
Recalls CDRH Recalls
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