FDA 510(k) Application Details - K001245

Device Classification Name	Cpb Check Valve, Retrograde Flow, In-Line   More FDA Info for this Device
510(K) Number	K001245
Device Name	Cpb Check Valve, Retrograde Flow, In-Line
Applicant	3T MEDICAL SYSTEMS, LLC. 6770 PINE WAY DR. TROY, MI 48098 US Other 510(k) Applications for this Company
Contact	TIMOTHY J SIMMONS 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	04/18/2000
Decision Date	08/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review