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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 K170407
FOIA Releasable 510(k) K170407
Device Name BD ChloraShield IV Dressing with CHG Antimicrobial
Applicant
Avery Dennison Belgie Bvba
Tieblokkenlaan 1
Turnhout,  BE b-2300
Applicant Contact Lisa Bartakovics
Correspondent
Avery Dennison Belgie Bvba
Tieblokkenlaan 1
Turnhout,  BE b-2300
Correspondent Contact Lisa Bartakovics
Classification Product Code
FRO  
Date Received02/10/2017
Decision Date 07/17/2017
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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