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

    CUI MAMMARY PROTHESIS SIZER

    K Number: K831566 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    11
    Review Days
    88

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    Basic Information

    Device Name
    CUI MAMMARY PROTHESIS SIZER
    K Number
    K831566
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Cox-Uphuff Intl.
    Date Received
    May 16, 1983
    Decision Date
    August 12, 1983
    Product Code
    MRD
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRD Mammary Sizer

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    Other Clearances by Cox-Uphuff Intl.

    K Number Device Name
    K874276 CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER
    K874342 LIGATURE CARRIER/PACKER, HYDROXYLAPATITE
    K873470 TEMPLATE
    K865056 CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER
    K871200 CUI NASAL SEPTUM BUTTON
    K865033 BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
    K854339 CUI CHIN SIZER
    K853945 CUI RHINOPLASTY IMPLANTS
    K813394 DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM
    K802214 COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
    Search all 11 clearances from Cox-Uphuff Intl. →