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

    THE OB-GYN CONCEPTS VAGINAL ASPIRATOR

    K Number: K863610 · Decision Jan 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
    K Number
    K863610
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Ob/Gyn Concepts, Ltd.
    Date Received
    September 16, 1986
    Decision Date
    January 7, 1987
    Product Code
    KOH
    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
    KOH Instrument, Manual, General Obstetric-Gynecologic

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    Other Clearances by Ob/Gyn Concepts, Ltd.

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