FDA 510(k) Application Details - K051828

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K051828
Device Name	Pump, Infusion, Elastomeric
Applicant	NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT LEXINGTON, KY 40514 US Other 510(k) Applications for this Company
Contact	KAELYN HADLEY 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	07/06/2005
Decision Date	12/15/2005
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