FDA 510(k) Application Details - K050770

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K050770
Device Name	Pump, Infusion, Elastomeric
Applicant	MCKINLEY MEDICAL LLC 4080 YOUNGFIELD WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	RALPH D COOEY 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	03/25/2005
Decision Date	04/14/2005
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