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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K230645
FOIA Releasable 510(k) K230645
Device Name BeneHold™ Surgical Incise Drape with CHG antimicrobial II
Applicant
Avery Dennison Medical , Ltd.
Ida Business Park, Ballinalee Rd.
Longford,  IE N39 RC80
Applicant Contact Lisa Bartakovics
Correspondent
Avery Dennison Medical , Ltd.
Ida Business Park, Ballinalee Rd.
Longford,  IE N39 DX73
Correspondent Contact Elaine Minagh
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/08/2023
Decision Date 10/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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