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

    TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)

    K Number: K061486 · Decision Aug 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    94
    Same Product Code
    183
    Applicant Total
    23
    Review Days
    62

    Basic Information

    Device Name
    TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
    K Number
    K061486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PROCTER & GAMBLE CO.
    Date Received
    May 31, 2006
    Decision Date
    August 1, 2006
    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 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
    K051290 TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
    K040999 TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
    K040312 TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
    K012629 ALWAYS DUETS
    Search all 23 clearances from PROCTER & GAMBLE CO. →