FDA 510(k) Application Details - K982712

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K982712
Device Name	Apparatus, Autotransfusion
Applicant	GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. FALL RIVER, MA 02720-4740 US Other 510(k) Applications for this Company
Contact	STEPHEN M PAGE 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	08/04/1998
Decision Date	12/18/1998
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