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

    DRAINAGE TUBE RESTRAINT/WOUND COVER

    K Number: K905766 · Decision Mar 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    6
    Review Days
    69

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    Basic Information

    Device Name
    DRAINAGE TUBE RESTRAINT/WOUND COVER
    K Number
    K905766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    M. Imonti and Associates Inc.,
    Date Received
    December 27, 1990
    Decision Date
    March 6, 1991
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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