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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 K131384
Device Name KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
Applicant
Kericure, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact JONATHAN WARD
Correspondent
Kericure, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JONATHAN WARD
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/14/2013
Decision Date 08/07/2014
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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