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

    MISHLER 2 CHAMB FLUSHING VALVE,STAND

    K Number: K760784 · Decision Nov 1, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    9
    Review Days
    27

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    Basic Information

    Device Name
    MISHLER 2 CHAMB FLUSHING VALVE,STAND
    K Number
    K760784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Heyer Schulte Corp.
    Date Received
    October 5, 1976
    Decision Date
    November 1, 1976
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    K780417 ASEPTIC TRANSFER SET
    K771224 RADOVAN SUBCUTANEOUS TISSUE EXPANDER
    K760778 T-TUBE DRAIN, ROUND
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    K760501 VALVE, STANDARD MODEL PUDENZE FLUSHING