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

    MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS

    K Number: K902019 · Decision Jun 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
    K Number
    K902019
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Gynescope Corp.
    Date Received
    May 3, 1990
    Decision Date
    June 7, 1990
    Product Code
    HDF
    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
    HDF Speculum, Vaginal, Metal

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