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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 K162129
Device Name RENASYS-G Gauze Dressing Kits with Soft Port
Applicant
Smith & Nephew, Inc.
970 Lake Carillon Dr., Suite 300
St Petersburg,  FL  33716
Applicant Contact Laura Reynolds
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr., Suite 300
St Petersburg,  FL  33716
Correspondent Contact Laura Reynolds
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/01/2016
Decision Date 08/31/2016
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 Yes
Predetermined Change
Control Plan Authorized		 No
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