FDA 510(k) Application Details - K040355

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K040355
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2004
Decision Date	03/15/2004
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