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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 K922074
Device Name DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK
Applicant
Danby Medical , Ltd.
Mustang Rd.
Earls Colne Industrial Park
Earls Colne, Essex,  GB CO6 2NS
Applicant Contact HORNE
Correspondent
Danby Medical , Ltd.
Mustang Rd.
Earls Colne Industrial Park
Earls Colne, Essex,  GB CO6 2NS
Correspondent Contact HORNE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/04/1992
Decision Date 01/22/1993
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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