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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K161050
Device Name ACTABOND Topical Skin Adhesive
Applicant
Bergen Medical Products, Inc.
16 Wing Dr.
Cedar Knolls,  NJ  07927
Applicant Contact Tom Stephens
Correspondent
Bergen Medical Products, Inc.
16 Wing Dr.
Cedar Knolls,  NJ  07927
Correspondent Contact Tom Stephens
Regulation Number878.4010
Classification Product Code
MPN  
Date Received04/14/2016
Decision Date 10/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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