FDA 510(k) Application Details - K993189

Device Classification Name	Tubing, Pump, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K993189
Device Name	Tubing, Pump, Cardiopulmonary Bypass
Applicant	TERUMO CORP. 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	GARRY A COURTNEY Other 510(k) Applications for this Contact
Regulation Number	870.4390   More FDA Info for this Regulation Number
Classification Product Code	DWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/1999
Decision Date	03/01/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review