FDA 510(k) Application Details - K021678

Device Classification Name	More FDA Info for this Device
510(K) Number	K021678
Device Name	HEMADERM COTAINING HEMADEX CLOTTING BEADS
Applicant	MEDAFOR, INC. 5201 EAST RIVER ROAD, # 312 MINNEAPOLIS, MN 55421-1035 US Other 510(k) Applications for this Company
Contact	PHILIP B JARVI 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	05/21/2002
Decision Date	07/12/2002
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