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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 K142979
Device Name RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
Applicant
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Applicant Contact Laurea Reynolds
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Correspondent Contact Laurea Reynolds
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/15/2014
Decision Date 04/29/2015
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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