FDA 510(k) Application Details - K993062

Device Classification Name	Tubing, Pump, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K993062
Device Name	Tubing, Pump, Cardiopulmonary Bypass
Applicant	OLSON MEDICAL SALES, INC. 2101 COTTONTAIL LN. SOMERSET, NJ 08873 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	09/13/1999
Decision Date	12/10/1999
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