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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K223526
Device Name ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Applicant
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Applicant Contact Hannah Sharp
Correspondent
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Correspondent Contact Hannah Sharp
Classification Product Code
FRO  
Date Received11/23/2022
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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