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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K242146
Device Name BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
Applicant
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2BN
Applicant Contact Andrew Daglish
Correspondent
Smith & Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2BN
Correspondent Contact Andrew Daglish
Classification Product Code
KGN  
Subsequent Product Code
FRO  
Date Received07/23/2024
Decision Date 12/17/2024
Decision Substantially Equivalent (SESE)
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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