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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 K202783
Device Name Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Applicant
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Applicant Contact Steeve Lamvohee
Correspondent
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Correspondent Contact Steeve Lamvohee
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/22/2020
Decision Date 01/14/2022
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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