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

    SI-PRO

    K Number: K904389 · Decision Dec 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    82

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    Basic Information

    Device Name
    SI-PRO
    K Number
    K904389
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    David F. Trungale
    Date Received
    September 26, 1990
    Decision Date
    December 17, 1990
    Product Code
    EYF
    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
    EYF Protector, Wound, Plastic

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