FDA 510(k) Application Details - K071936

Device Classification Name	More FDA Info for this Device
510(K) Number	K071936
Device Name	WOUNDSTAT, MODEL TC1001
Applicant	TRAUMACURE INC. 2001 PENNSYLVANIA AVE. SUITE 950 WASHINGTON, DC 20006 US Other 510(k) Applications for this Company
Contact	CAMPBELL HUTTON 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	07/13/2007
Decision Date	08/23/2007
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