FDA 510(k) Application Details - K131384

Device Classification Name Bandage, Liquid

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510(K) Number K131384
Device Name Bandage, Liquid
Applicant KERICURE INC.
445 APOLLO BEACH BLVD
APOLLO BEACH, FL 33572 US
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Contact JONATHAN WARD
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 05/14/2013
Decision Date 08/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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