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

    PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY

    K Number: K955790 · Decision Mar 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    90

    Basic Information

    Device Name
    PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY
    K Number
    K955790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TRYLON CORP.
    Date Received
    December 22, 1995
    Decision Date
    March 21, 1996
    Product Code
    HIC
    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
    HIC Speculum, Vaginal, Nonmetal, Fiberoptic

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