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

    BYRD STAINLESS STEEL DILATOR

    K Number: K902502 · Decision Aug 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    BYRD STAINLESS STEEL DILATOR
    K Number
    K902502
    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
    June 5, 1990
    Decision Date
    August 7, 1990
    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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