FDA 510(k) Application Details - K982406

Device Classification Name	Cpb Check Valve, Retrograde Flow, In-Line   More FDA Info for this Device
510(K) Number	K982406
Device Name	Cpb Check Valve, Retrograde Flow, In-Line
Applicant	COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	LYNNE LEONARD Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	MJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/1998
Decision Date	10/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review