FDA 510(k) Application Details - K112245

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K112245
Device Name	Apparatus, Autotransfusion
Applicant	SORIN GROUP ITALIA S.R.L PAREXEL CONSULTING 195 WEST STREET WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	BARRY SALL 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	08/04/2011
Decision Date	09/06/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review