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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 K163529
FOIA Releasable 510(k) K163529
Device Name ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
Applicant
Avery Dennison Corporation
7100 Lindsay Dr. Bldg. 14
Mentor,  OH  44060
Applicant Contact LISA BARTAKOVICS
Correspondent
Avery Dennison Corporation
7100 Lindsay Dr. Bldg. 14
Mentor,  OH  44060
Correspondent Contact LISA BARTAKOVICS
Classification Product Code
FRO  
Date Received12/16/2016
Decision Date 03/29/2017
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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