FDA 510(k) Application Details - K102459

Device Classification Name	More FDA Info for this Device
510(K) Number	K102459
Device Name	NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
Applicant	HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH 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	08/27/2010
Decision Date	12/03/2010
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