BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

    K Number: K000420 · Decision May 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
    K Number
    K000420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Retinalabs.Com
    Date Received
    February 8, 2000
    Decision Date
    May 8, 2000
    Product Code
    MRH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRH Pump, Infusion, Ophthalmic

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    Other Clearances by Retinalabs.Com

    K Number Device Name
    K003036 TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
    K000418 PDT DOSECALCULATOR, MODEL 80000
    K000457 VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
    K000416 TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001