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

    SER-TEX

    K Number: K800834 · Decision Jun 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    SER-TEX
    K Number
    K800834
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    V.S.S.I., Inc.
    Date Received
    April 14, 1980
    Decision Date
    June 30, 1980
    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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