FDA 510(k) Application Details - K140573

Device Classification Name	More FDA Info for this Device
510(K) Number	K140573
Device Name	WOUNDCLOT HEMOSTATIC GAUZE
Applicant	CORE SCIENTIFIC LTD. POB 3 SHAVE-ZION 22806 IL Other 510(k) Applications for this Company
Contact	Sigalit Ariely-Portnoy 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	03/06/2014
Decision Date	11/24/2014
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