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

    TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS

    K Number: K040312 · Decision May 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    23
    Review Days
    84

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    Basic Information

    Device Name
    TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
    K Number
    K040312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Procter & Gamble Co.
    Date Received
    February 9, 2004
    Decision Date
    May 3, 2004
    Product Code
    HIL
    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
    HIL Tampon, Menstrual, Scented, Scented-Deodorized

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.

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    Other Clearances by Procter & Gamble Co.

    K Number Device Name
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    K131543 TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
    K091281 TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
    K091964 CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
    K081555 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
    K062638 TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
    K061486 TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
    K051290 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
    K040999 TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
    K012629 ALWAYS DUETS
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