FDA 510(k) Application Details - K012293

Device Classification Name	More FDA Info for this Device
510(K) Number	K012293
Device Name	VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
Applicant	VASCULAR SOLUTIONS, INC. 2495 XENIUM LN. NORTH MINNEAPOLIS, MN 55441 US Other 510(k) Applications for this Company
Contact	DEBORAH L JENSEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2001
Decision Date	01/18/2002
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