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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 K911103
Device Name DANBY D.S.P. SYRINGE PUMP
Applicant
Isys Medical , Ltd.
Mustang Rd., Earl Colne
Industrial Park, Earls Colne
Essex, England,  GB C06 2NS
Applicant Contact TOM HORNE
Correspondent
Isys Medical , Ltd.
Mustang Rd., Earl Colne
Industrial Park, Earls Colne
Essex, England,  GB C06 2NS
Correspondent Contact TOM HORNE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/12/1991
Decision Date 11/08/1991
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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