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510(k) Data Aggregation

    K Number
    K070545
    Device Name
    K-Y BRAND WARMING LIQUID
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    2007-03-23

    (25 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.
    Device Description
    This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.
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    K Number
    K062796
    Device Name
    K-Y BRAND INTRIGUE
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    2006-12-08

    (80 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
    Device Description
    This device is a personal lubricant compatible with latex condom.
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    K Number
    K021492
    Device Name
    K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
    Manufacturer
    PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
    Date Cleared
    2002-08-07

    (90 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO., DIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricant (compatible with latex condoms)
    Device Description
    K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
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    K Number
    K020827
    Device Name
    K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
    Manufacturer
    PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.
    Date Cleared
    2002-06-12

    (90 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO., DIV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricant compatible with latex condoms, helps enhance intimacy
    Device Description
    K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
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    K Number
    K010365
    Device Name
    ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    2001-04-30

    (82 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990536
    Device Name
    O.B. TAMPON
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1999-08-31

    (193 days)

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

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
    Device Description
    o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range. o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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    K Number
    K991118
    Device Name
    O.B. APPLICATOR TAMPONS, O.B. TAMPONS
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1999-06-29

    (89 days)

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

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.
    Device Description
    o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges. o.b.® non-applicator and applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
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    K Number
    K974629
    Device Name
    O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1998-02-10

    (60 days)

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

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
    Device Description
    o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
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    K Number
    K971589
    Device Name
    REACH ANTIBACTERIAL TOOTHBRUSH
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1997-07-24

    (84 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush.
    Device Description
    Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.
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    K Number
    K970954
    Device Name
    O.B. APPLICATOR TAMPONS
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1997-06-10

    (85 days)

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

    PERSONAL PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge.
    Device Description
    o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies. o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
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