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

    CATHETEO CARE TRAY #0242

    K Number: K771673 · Decision Sep 30, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    42
    Review Days
    28

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    Basic Information

    Device Name
    CATHETEO CARE TRAY #0242
    K Number
    K771673
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Concord Laboratories, Inc.
    Date Received
    September 2, 1977
    Decision Date
    September 30, 1977
    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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