FDA 510(k) Application Details - K080648

Device Classification Name	More FDA Info for this Device
510(K) Number	K080648
Device Name	TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
Applicant	ORE-MEDIX, LLC 7651 S. 700 WEST, SUITE 105 MIDVALE, UT 84047 US Other 510(k) Applications for this Company
Contact	DONALD F GRABARZ 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	03/07/2008
Decision Date	05/07/2008
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	Y