FDA 510(k) Application Details - K980762

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K980762
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant	PALL CORP. 2200 NORTHERN BLVD. EAST HILLS, NY 11548 US Other 510(k) Applications for this Company
Contact	ROBERT A DICKSTEIN, PH.D. Other 510(k) Applications for this Contact
Regulation Number	870.4260   More FDA Info for this Regulation Number
Classification Product Code	DTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/1998
Decision Date	09/01/1998
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