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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 K202208
Device Name BeneHold Surgical Incise Drape with CHG antimicrobial
Applicant
Avery Dennison Belgie Bvba
Tieblokkenlaan, 1
Turnhout,  BE 2300
Applicant Contact Lisa Bartakovics
Correspondent
Avery Dennison Belgie Bvba
Tieblokkenlaan, 1
Turnhout,  BE 2300
Correspondent Contact Lisa Bartakovics
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/06/2020
Decision Date 07/30/2021
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 No
Predetermined Change
Control Plan Authorized		 No
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