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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 K843878
Device Name HEPARIN INFUSIN PUMP
Applicant
ARMAMENT SYSTEMS, INC.
712-F NORTH VALLEY STREET
ANAHEIM,  CA  92801 -
Applicant Contact JEROME C JOERGER
Correspondent
ARMAMENT SYSTEMS, INC.
712-F NORTH VALLEY STREET
ANAHEIM,  CA  92801 -
Correspondent Contact JEROME C JOERGER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/02/1984
Decision Date 12/06/1984
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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