FDA 510(k) Application Details - K981284

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K981284
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. OYSTER BAY, NY 11771 US Other 510(k) Applications for this Company
Contact	YEHUDA TAMARI Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1998
Decision Date	08/12/1998
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