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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K241916
Device Name TearRepair Liquid Skin Protectant
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 Allison Komiyama
Regulation Number880.5090
Classification Product Code
KMF  
Date Received07/01/2024
Decision Date 09/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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