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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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