FDA 510(k) Application Details - K131517

Device Classification Name	Tubing, Fluid Delivery   More FDA Info for this Device
510(K) Number	K131517
Device Name	Tubing, Fluid Delivery
Applicant	MEDRAD, INC. / BAYER MEDICAL CARE, INC. ONE MEDRAD DR. INDIANOLA, PA 15051 US Other 510(k) Applications for this Company
Contact	LISA A EWING Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2013
Decision Date	08/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review