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

    MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

    K Number: K010709 · Decision Apr 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    61
    Review Days
    45

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    Basic Information

    Device Name
    MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
    K Number
    K010709
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mentor Corp.
    Date Received
    March 9, 2001
    Decision Date
    April 23, 2001
    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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