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

    MITRATHANE DRESSING

    K Number: K850535 · Decision Jun 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    MITRATHANE DRESSING
    K Number
    K850535
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Mitral Medical , Ltd.
    Date Received
    February 11, 1985
    Decision Date
    June 5, 1985
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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