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

    MODIFIED UNTREATED TAMPAX TAMPONS

    K Number: K780648 · Decision May 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    12
    Review Days
    44

    Basic Information

    Device Name
    MODIFIED UNTREATED TAMPAX TAMPONS
    K Number
    K780648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Tampax, Inc.
    Date Received
    April 17, 1978
    Decision Date
    May 31, 1978
    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 Tampax, Inc.

    K Number Device Name
    K832972 REGULAR DEODORANT MAXITHINS PADS
    K832973 TAMPAX SUPER DEODORANT MAXITHINS
    K832971 DEODORANT MAXITHINS PANTY SHIELD
    K832974 MAXITHINS UNSCENTED PANTY SHIELDS
    K821800 REGULAR MAXITHINS PADS & SUPER MAXITHINS
    K820174 TAMPAX TAMPONS
    K813642 PETAL SOFT PLASTIC APPLICATOR TAMPAX
    K810143 TAMPAX DEODORANT TAMPONS
    K810160 TAMPAX MAXITHINS PADS
    K802760 PETAL SOFT PLASTIC APPLICATOR TAMPAX
    Search all 12 clearances from Tampax, Inc. →