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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
Correspodent 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
Recalls CDRH Recalls
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