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

    BYRD EXTRACTOR SET

    K Number: K893480 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    BYRD EXTRACTOR SET
    K Number
    K893480
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Engineering and Development Institute
    Date Received
    May 4, 1989
    Decision Date
    June 23, 1989
    Product Code
    GCC
    Advisory Committee
    General, Plastic Surgery
    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
    GCC Dilator, Catheter

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