FDA 510(k) Application Details - K133147

Device Classification Name	More FDA Info for this Device
510(K) Number	K133147
Device Name	BRACCO INJEENERING TRANSFER SET
Applicant	BRACCO INJENEERING S.A. P O BOX 3018 NEDERLAND, CO 80466 US Other 510(k) Applications for this Company
Contact	THOMAS KROENKE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2013
Decision Date	06/20/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review