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510(k) Data Aggregation

    K Number
    K983381
    Device Name
    VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
    Date Cleared
    1998-10-19

    (24 days)

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

    PARAGON TRADE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid. As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
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    K Number
    K981953
    Device Name
    VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
    Date Cleared
    1998-08-18

    (76 days)

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

    PARAGON TRADE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Paragon Menstrual Tampons are a plug made of cellulosic or synthetic material that is inserted into the vaginal and used to absorb menstrual or other vaginal discharge.
    Device Description
    Paragon Trade Brands Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons.
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    K Number
    K962953
    Device Name
    DEODORANT PANTY SHIELD
    Date Cleared
    1996-10-10

    (72 days)

    Product Code
    Regulation Number
    884.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARAGON TRADE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962954
    Device Name
    DEODORANT MAXI PAD
    Date Cleared
    1996-10-10

    (72 days)

    Product Code
    Regulation Number
    884.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARAGON TRADE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962962
    Device Name
    DEODORANT PANTY LINER
    Date Cleared
    1996-10-10

    (72 days)

    Product Code
    Regulation Number
    884.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARAGON TRADE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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