FDA 510(k) Application Details - K061767

Device Classification Name	More FDA Info for this Device
510(K) Number	K061767
Device Name	QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
Applicant	Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	ROBERT V PACKARD 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	06/23/2006
Decision Date	07/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review