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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, Elastomeric
510(k) Number K050770
Device Name MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
Applicant
Mckinley Medical, LLC
4080 Youngfield
Wheat Ridge,  CO  80033
Applicant Contact RALPH D COOEY
Correspondent
Mckinley Medical, LLC
4080 Youngfield
Wheat Ridge,  CO  80033
Correspondent Contact RALPH D COOEY
Regulation Number880.5725
Classification Product Code
MEB  
Date Received03/25/2005
Decision Date 04/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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