FDA 510(k) Application Details - K092552

Device Classification Name	More FDA Info for this Device
510(K) Number	K092552
Device Name	CLO-SURPLUS P.A.D.
Applicant	SCION CARDIO-VASCULAR, INC. 14256 SW 119TH AVE. MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	DENNIS HAMMOND 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	08/20/2009
Decision Date	09/04/2009
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