FDA 510(k) Application Details - K043140

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K043140
Device Name	Apparatus, Autotransfusion
Applicant	ATRIUM MEDICAL CORP. 5 WENTWORTH DR. HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	JOSEPH P DE PAOLO 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	11/15/2004
Decision Date	12/08/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review