FDA 510(k) Application Details - K151650

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K151650
Device Name	Pump, Infusion, Elastomeric
Applicant	Epic Medical Pte Ltd 545 Orchard Road, #09-0 Singapore 238882 SG Other 510(k) Applications for this Company
Contact	Freddie Lee 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	06/18/2015
Decision Date	04/04/2016
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	Y
Expedited Review