FDA 510(k) Application Details - K031554

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K031554
Device Name	Apparatus, Autotransfusion
Applicant	GENZYME BIOSURGERY 600 AIRPORT RD. FALL RIVER, MA 02720-4740 US Other 510(k) Applications for this Company
Contact	DENISE LIMA Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2003
Decision Date	07/25/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review