BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MOUTH-TO-MOUTH SHIELD APPLICATOR

    K Number: K832590 · Decision Oct 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    MOUTH-TO-MOUTH SHIELD APPLICATOR
    K Number
    K832590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3270
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Mem, Inc.
    Date Received
    August 2, 1983
    Decision Date
    October 14, 1983
    Product Code
    LAE
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LAE High Pressure Liquid Chromatography, Codeine

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    Other Clearances by Mem, Inc.

    K Number Device Name
    K842599 METER MOUSE SYSTEM