Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K081236
    Device Name
    K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2008-09-25

    (147 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.
    Device Description
    This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.
    Ask a Question
    K Number
    K072421
    Device Name
    K-Y BRAND YOURS+MINE
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2008-03-06

    (191 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
    Device Description
    The devices are personal lubricants compatible with latex condom.
    Ask a Question
    K Number
    K072360
    Device Name
    K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2007-12-12

    (112 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand Intrigue™ Intense Warming Sensation 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.
    Ask a Question
    K Number
    K062535
    Device Name
    K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2007-01-26

    (150 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.
    Device Description
    This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.
    Ask a Question
    K Number
    K053397
    Device Name
    K-Y BRAND SENSUAL MIST
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2006-02-17

    (73 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.
    Device Description
    This device is a condom compatible personal lubricant that has been specifically developed to be delivered via a non-aerosol spray pump.
    Ask a Question
    K Number
    K023789
    Device Name
    O.B. TAMPONS
    Manufacturer
    MCNEIL-PPC, INC.
    Date Cleared
    2002-12-06

    (23 days)

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

    MCNEIL-PPC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
    Device Description
    The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.
    Ask a Question

    Page 1 of 1