FDA 510(k) Application Details - K123394

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K123394
Device Name	Dressing, Wound, Drug
Applicant	CORELEADER BIOTECH CO., LTD. 19F NO. 100, SEC 1 SINTAI 5TH RD, SIJHIH DIST NEW TAIPEI, TAIWAN 22102 TW Other 510(k) Applications for this Company
Contact	VINCENT HUANG 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	11/02/2012
Decision Date	06/06/2013
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