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

    DOSIMETRY RELEASE OF RADIATION STERILIZ

    K Number: K831512 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    53
    Applicant Total
    441
    Review Days
    140

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    Basic Information

    Device Name
    DOSIMETRY RELEASE OF RADIATION STERILIZ
    K Number
    K831512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biomet, Inc.
    Date Received
    May 12, 1983
    Decision Date
    September 29, 1983
    Product Code
    JDK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JDK Prosthesis, Hip, Cement Restrictor

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