FDA 510(k) Application Details - K032986

Device Classification Name	More FDA Info for this Device
510(K) Number	K032986
Device Name	CLO-SURPLUSP.A.D.
Applicant	SCION CARDIO-VASCULAR, INC. 14256 SW 119 AVE. MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	RAMON AUGUSTO PAZ 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	09/24/2003
Decision Date	03/01/2004
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