FDA 510(k) Application Details - K971966

Device Classification Name	Marker, Ostia, Aorto-Saphenous Vein   More FDA Info for this Device
510(K) Number	K971966
Device Name	Marker, Ostia, Aorto-Saphenous Vein
Applicant	MED-EDGE, INC. 1843 PINEHURST DR. CLEMMONS, NC 27012 US Other 510(k) Applications for this Company
Contact	STEVE OWENBY Other 510(k) Applications for this Contact
Regulation Number	878.4650   More FDA Info for this Regulation Number
Classification Product Code	KPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/1997
Decision Date	01/26/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review