FDA 510(k) Application Details - K163430

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K163430
Device Name	Dressing, Wound, Drug
Applicant	B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 US Other 510(k) Applications for this Company
Contact	Nancy Skocypec 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	12/07/2016
Decision Date	05/23/2017
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