FDA 510(k) Application Details - K061031

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K061031
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	SORIN GROUP ITALIA S.R.L. 200 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	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2006
Decision Date	06/02/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review