FDA 510(k) Application Details - K153138

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K153138
Device Name	Dressing, Wound, Drug
Applicant	BU POLYSCIENCES EQUIPMENT & TRADING, LLC 10855 SYMPHONY PARK DR. NORTH BETHESDA, MD 20852 US Other 510(k) Applications for this Company
Contact	N. T. UMAMAHESWARAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2015
Decision Date	06/23/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review