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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 K033039
Device Name MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
Applicant
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Applicant Contact ANDREW N LAMBORNE
Correspondent
MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE,  CO  80033
Correspondent Contact ANDREW N LAMBORNE
Regulation Number880.5725
Classification Product Code
MEB  
Date Received09/29/2003
Decision Date 10/07/2003
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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