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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 K082211
Device Name RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
Applicant
Smith & Nephew, Inc
970 LAKE CARILLON DRIVE,
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA KREJCI
Correspondent
Smith & Nephew, Inc
970 LAKE CARILLON DRIVE,
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA KREJCI
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/06/2008
Decision Date 11/14/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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