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

    PELVIC EXAM TRAY

    K Number: K800874 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    307
    Registration Numbers
    307
    Same Product Code
    135
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    PELVIC EXAM TRAY
    K Number
    K800874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5435
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Laboratories
    Date Received
    April 17, 1980
    Decision Date
    May 8, 1980
    Product Code
    HHD
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHD Pad, Menstrual, Unscented

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    Other Clearances by Pharmaseal Laboratories

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