FDA 510(k) Application Details - K130520

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K130520
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	ASHITAKA FACTORY OF TERUMO CORP. 150 MAIMAIGI-CHO FUJINOMIYA, SHIZUOKA 418-0015 JP Other 510(k) Applications for this Company
Contact	EILEEN DORSEY 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	02/28/2013
Decision Date	03/13/2013
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