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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K032642
Device Name BEELINE SYSTEM
Applicant
Mckinley, Inc.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact ANDY LAMBORNE
Correspondent
Mckinley, Inc.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact ANDY LAMBORNE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/27/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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