FDA 510(k) Application Details - K982014

Device Classification Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K982014
Device Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant	STOECKERT INSTRUMENTE 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON Other 510(k) Applications for this Contact
Regulation Number	870.4220   More FDA Info for this Regulation Number
Classification Product Code	DTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/1998
Decision Date	09/04/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review