FDA 510(k) Application Details - K171148

Device Classification Name Bandage, Liquid

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510(K) Number K171148
Device Name Bandage, Liquid
Applicant Aleo BME Inc.
200 Innovations Blvd, Ste. 210A
State College, PA 16803 US
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Contact Chao Liu
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 04/19/2017
Decision Date 01/12/2018
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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