FDA 510(k) Application Details - K131249

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K131249
Device Name	Pump, Infusion, Elastomeric
Applicant	I-FLOW LLC 43 Discovery Suite 100 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	SHELLY HARRIS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2013
Decision Date	02/03/2014
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