BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HENSCHKE AFTERLOADING APPLICATOR

    K Number: K871217 · Decision Jul 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    35
    Applicant Total
    43
    Review Days
    112

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    Basic Information

    Device Name
    HENSCHKE AFTERLOADING APPLICATOR
    K Number
    K871217
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Mick Radio-Nuclear Instruments, Inc.
    Date Received
    March 26, 1987
    Decision Date
    July 16, 1987
    Product Code
    IWJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IWJ System, Applicator, Radionuclide, Manual

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