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

    SPECULITE

    K Number: K953364 · Decision Dec 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    7
    Review Days
    144

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    Basic Information

    Device Name
    SPECULITE
    K Number
    K953364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trylon Corp.
    Date Received
    July 17, 1995
    Decision Date
    December 8, 1995
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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