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510(k) Data Aggregation

    K Number
    K102445
    Device Name
    ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2010-11-10

    (76 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rostan Scented and Unscented Biodegradable Plastic Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Rostam plastic scented and unscented biodegradable applicator tampons are being submitted to obtain clearance for a new material applicator. They are menstrual tampons used to absorb menstrual fluid. These Tanıpons will be provided with 4 absorbencies, light, regular, super and super plus. These Tampons are made from rayon and/or cotton (as the absorbent material) polymeric overwrap, cotton/polyester sewing thread and cotton cord.
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    K Number
    K090071
    Device Name
    ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2009-05-28

    (136 days)

    Product Code
    HEB, HIL
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge
    Device Description
    Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, Light, regular and super. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
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    K Number
    K062001
    Device Name
    ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2006-12-07

    (146 days)

    Product Code
    HEB, HIL
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rostam Ltd. Fragranced and Unfragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to apsorb menstrual or other vaginal discharge
    Device Description
    Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided as two absorbencies, slender regular and light. These Tampons are made from rayon and/or cotton, polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
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    K Number
    K042773
    Device Name
    ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2004-11-23

    (49 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470). Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons.
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    K Number
    K030474
    Device Name
    PH BUFFERING PLASTIC APPLICATOR TAMPON
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2004-05-28

    (471 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
    Device Description
    The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses. These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.
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    K Number
    K032080
    Device Name
    ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2003-08-14

    (38 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rostam Ltd fragranced plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons.
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    K Number
    K020535
    Device Name
    INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2002-05-09

    (79 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.
    Device Description
    Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.
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    K Number
    K001641
    Device Name
    TAMPONS
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    2000-08-03

    (65 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K965064
    Device Name
    ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
    Manufacturer
    ROSTAM LTD.
    Date Cleared
    1997-02-20

    (64 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSTAM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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