BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇮 Slovenia

    Tosama Biobased Applicator Tube Menstrual Tampon

    K Number: K172504 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    5
    Review Days
    175

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    Basic Information

    Device Name
    Tosama Biobased Applicator Tube Menstrual Tampon
    K Number
    K172504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tosama, D.O.O.
    Date Received
    August 18, 2017
    Decision Date
    February 9, 2018
    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 Tosama, D.O.O.

    K Number Device Name
    K232060 TOSAMA Reusable Applicator
    K151170 Tosama 100% Organic Cotton Menstrual Tampon
    K150897 Tosama 100% Cotton Menstrual Tampon
    K120481 LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,