FDA 510(k) Application Details - K122886

Device Classification Name	More FDA Info for this Device
510(K) Number	K122886
Device Name	NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
Applicant	HEMOSTASIS, LLC 4486 TIMBERLINE CT VADNAIS HTS, MN 55127 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	09/20/2012
Decision Date	11/15/2012
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