FDA 510(k) Application Details - K143462

Device Classification Name	More FDA Info for this Device
510(K) Number	K143462
Device Name	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
Applicant	BENQ MATERIALS CORPORATION NO. 29, JIANGUO E. RD GUISHAN TAOYUAN 33341 TW Other 510(k) Applications for this Company
Contact	Kenix Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2014
Decision Date	05/08/2015
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