FDA 510(k) Application Details - K031544

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K031544
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	JOSTRA AB 2828 N. CRESCENT RIDGE DR. THE WOODLANDS, TX 77381 US Other 510(k) Applications for this Company
Contact	LE ANN LATHAM Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2003
Decision Date	08/07/2003
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