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

    ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS

    K Number: K102445 · Decision Nov 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    9
    Review Days
    76

    Basic Information

    Device Name
    ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
    K Number
    K102445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rostam , Ltd.
    Date Received
    August 26, 2010
    Decision Date
    November 10, 2010
    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 Rostam , Ltd.

    K Number Device Name
    K090071 ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
    K062001 ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
    K042773 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