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510(k) Data Aggregation

    K Number
    K073662
    Device Name
    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2008-01-17

    (22 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K072376
    Device Name
    PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2007-12-12

    (110 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K070745
    Device Name
    MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2007-04-13

    (25 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K061013
    Device Name
    PLAYTEX EMBRACE PETITE BREAST PUMP
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2006-08-15

    (124 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An electrically powered breast pump used to express milk from the breast of a lactating woman.
    Device Description
    The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 3 major assemblies: a pump assembly, a breast cup assembly, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 1 pre-set speed level and 3 pre-set suction setings, which are selectable by the user via a rotating dial. The device is powered by a 12V DC power supply, which is included with the package.
    Ask a Question
    K Number
    K060981
    Device Name
    PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2006-05-09

    (29 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K032636
    Device Name
    PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2003-11-14

    (79 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    unscented tampons for the absorption of menstrual fluid
    Device Description
    Unscented menstrual tampons for the absorption of menstrual fluid. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginat wall are the same or have the same mode of action.
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    K Number
    K022594
    Device Name
    PLAYTEX BREAST PUMP
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2002-11-01

    (88 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An electrically powered breast pump used to express milk from the breast of a lactating woman.
    Device Description
    The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 4 major assemblies: a pump assembly, a breast cup assembly, a carry bag, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 5 pre-set suction levels and 5 pre-set speed settings, which are selectable by the user via a button pad. The device is powered by a 12V DC power supply, which is included with the package.
    Ask a Question
    K Number
    K022882
    Device Name
    MODIFICATION TO PLAYTEX TAMPONS #24002
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2002-09-16

    (17 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented, Unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K020200
    Device Name
    PLAYTEX DEODORANT TAMPONS, MODEL 34802
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2002-03-13

    (50 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
    Ask a Question
    K Number
    K020201
    Device Name
    PLAYTEX DEODORANT TAMPONS, MODEL 34902
    Manufacturer
    PLAYTEX PRODUCTS, INC.
    Date Cleared
    2002-03-12

    (49 days)

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

    PLAYTEX PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.
    Device Description
    Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
    Ask a Question

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