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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 K981816
Device Name CUE AMBULATORY VOLUMETRIC INFUSION PUMP
Applicant
BECTON DICKINSON CURLIN, LLC.
15751 GRAHAM ST.
HUNTINGTON BEACH,  CA  92649
Applicant Contact CHARLES J WELLE
Correspondent
BECTON DICKINSON CURLIN, LLC.
15751 GRAHAM ST.
HUNTINGTON BEACH,  CA  92649
Correspondent Contact CHARLES J WELLE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/22/1998
Decision Date 12/04/1998
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
Recalls CDRH Recalls
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