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

    IMPLANT SCIENCES CORP. MODEL HDR 4454

    K Number: K070468 · Decision Mar 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    IMPLANT SCIENCES CORP. MODEL HDR 4454
    K Number
    K070468
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implant Sciences Corp.
    Date Received
    February 16, 2007
    Decision Date
    March 23, 2007
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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    Other Clearances by Implant Sciences Corp.

    K Number Device Name
    K042864 IMPLANT SCIENCES CORP, MODEL HDR-4140
    K023073 SEED LINK
    K023242 I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE
    K994317 I-PLANT, MODEL 3500
    K990193 IODINE BRACHYTHERAPY SEEDS, MODEL 3000