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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 K243990
Device Name BondEase 2 Topical Skin Adhesive
Applicant
Optmed, Inc.
745 Fifth Ave.
Suite 500
New York,  NY  10151
Applicant Contact Nitasha Yajnik
Correspondent
RQM+
2790 Mosside Blvd.
Suite 800
Monroeville,  PA  15146
Correspondent Contact Lucie Dalet
Regulation Number878.4010
Classification Product Code
MPN  
Date Received12/26/2024
Decision Date 09/19/2025
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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