BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NATRACAREN APPLICATOR TAMPON

    K Number: K954942 · Decision Jan 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    NATRACAREN APPLICATOR TAMPON
    K Number
    K954942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bodywise (Uk), Ltd.
    Date Received
    October 30, 1995
    Decision Date
    January 25, 1996
    Product Code
    HEB
    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
    HEB Tampon, Menstrual, Unscented

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    Other Clearances by Bodywise (Uk), Ltd.

    K Number Device Name
    K914430 NATRACARE TAMPON