FDA 510(k) Application Details - K151204

Device Classification Name	More FDA Info for this Device
510(K) Number	K151204
Device Name	HEMO-Bandage
Applicant	CORELEADER BIOTECH CO., LTD. 19F BUILD B, NO. 100, SEC 1 XINTAI 5TH RD, XIZHI DIST. NEW TAIPEI CITY 22102 TW Other 510(k) Applications for this Company
Contact	Ya-Wen Kuo 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	05/05/2015
Decision Date	07/31/2015
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