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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 K243576
Device Name RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
Applicant
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Applicant Contact Ruby Uttley
Correspondent
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Correspondent Contact Ruby Uttley
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/19/2024
Decision Date 02/18/2025
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
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