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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 K110647
Device Name RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
Applicant
Smith & Nephew, Inc.
970 Lake Carillon Dr.
St. Petersburg,  FL  33716
Applicant Contact LAURA REYNOLDS
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr.
St. Petersburg,  FL  33716
Correspondent Contact LAURA REYNOLDS
Regulation Number878.4780
Classification Product Code
OMP  
Subsequent Product Code
BTA  
Date Received03/07/2011
Decision Date 06/22/2011
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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