FDA 510(k) Application Details - K160684

Device Classification Name Bandage, Liquid

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510(K) Number K160684
Device Name Bandage, Liquid
Applicant ROCHAL INDUSTRIES LLC
12719 CRANES MILL
SAN ANTONIO, TX 78230 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 03/11/2016
Decision Date 07/26/2016
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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