FDA 510(k) Application Details - K182733

Device Classification Name Bandage, Liquid

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510(K) Number K182733
Device Name Bandage, Liquid
Applicant Rochal Industries, LLC
12000 Network Blvd, Ste B200
San Antonio, TX 78249 US
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Contact William J. Coulston
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 09/28/2018
Decision Date 06/27/2019
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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