FDA 510(k) Application Details - K982385

Device Classification Name	Filter, Prebypass, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K982385
Device Name	Filter, Prebypass, Cardiopulmonary Bypass
Applicant	POROUS MEDIA CORP. 1350 HAMMOND RD. ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	ROCHELLE M MICKSCHL Other 510(k) Applications for this Contact
Regulation Number	870.4280   More FDA Info for this Regulation Number
Classification Product Code	KRJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/1998
Decision Date	02/01/1999
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