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

    ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS

    K Number: K042773 · Decision Nov 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    9
    Review Days
    49

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    Basic Information

    Device Name
    ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
    K Number
    K042773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rostam , Ltd.
    Date Received
    October 5, 2004
    Decision Date
    November 23, 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.

    ONTEX AND OTHERS PROPRIETARY NAMES

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    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

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    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

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    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

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    TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

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    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Rostam , Ltd.

    K Number Device Name
    K102445 ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
    K090071 ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
    K062001 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
    K030474 PH BUFFERING PLASTIC APPLICATOR TAMPON
    K032080 ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
    K020535 INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
    K001641 TAMPONS
    K965064 ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON