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

    REGANES RADIONUCLIDE SEED MAGAZINE

    K Number: K972554 · Decision Feb 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    35
    Applicant Total
    9
    Review Days
    224

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    Basic Information

    Device Name
    REGANES RADIONUCLIDE SEED MAGAZINE
    K Number
    K972554
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avid N.I.T., Inc.
    Date Received
    July 8, 1997
    Decision Date
    February 17, 1998
    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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    Other Clearances by Avid N.I.T., Inc.

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    K973638 N.I.T., INC. NEEDLE GUIDING TEMPLATE
    K971645 REGANES SPINAL NEEDLE (VARIOUS)
    K945965 ATRAUMATIC PENCIL POINT SPINAL NEEDLE