FDA 510(k) Application Details - K133261

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K133261
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	MEDOS MEDIZINTECHNIK AG 3526 WEST LIBERTY RD. ANN ARBOR, MI 48103 US Other 510(k) Applications for this Company
Contact	Leann Christman 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	10/23/2013
Decision Date	01/09/2014
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