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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 K912914
Device Name DANBY-DCR VOLUMETRIC INFUSION PUMP
Applicant
Danby Medical , Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact TOBY JOHNSTON
Correspondent
Danby Medical , Ltd.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact TOBY JOHNSTON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/03/1991
Decision Date 08/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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