FDA 510(k) Application Details - K990461

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K990461
Device Name	Pump, Infusion, Elastomeric
Applicant	MCKINLEY, INC. 4080 YOUNGFIELD ST. WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	JOHN MCINROY 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	02/12/1999
Decision Date	06/30/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review