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

    CUSTOM DRESSING CHANGE TRAYS

    K Number: K791738 · Decision Oct 2, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    10
    Review Days
    33

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    Basic Information

    Device Name
    CUSTOM DRESSING CHANGE TRAYS
    K Number
    K791738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sterile Design, Inc.
    Date Received
    August 30, 1979
    Decision Date
    October 2, 1979
    Product Code
    FMC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMC Patient Examination Glove

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