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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 K141157
Device Name BONDEASE TOPICAL SKIN ADHESIVE
Applicant
OPTMED, INC.
601 LEXINGTON AVENUE
SUITE 5100
NEW YORK,  NY  10022
Applicant Contact STEPHANIE RAIS
Correspondent
OPTMED, INC.
601 LEXINGTON AVENUE
SUITE 5100
NEW YORK,  NY  10022
Correspondent Contact STEPHANIE RAIS
Regulation Number878.4010
Classification Product Code
MPN  
Date Received05/05/2014
Decision Date 12/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01716013
Reviewed by Third Party No
Combination Product No
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