FDA 510(k) Application Details - K982891

Device Classification Name	Sucker, Cardiotomy Return, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K982891
Device Name	Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Applicant	CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	MEHMET BICAKCI Other 510(k) Applications for this Contact
Regulation Number	870.4420   More FDA Info for this Regulation Number
Classification Product Code	DTS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/1998
Decision Date	09/30/1998
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