BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME

    K Number: K081236 · Decision Sep 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
    K Number
    K081236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mcneil-Ppc, Inc.
    Date Received
    May 1, 2008
    Decision Date
    September 25, 2008
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUC Lubricant, Personal

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    Other Clearances by Mcneil-Ppc, Inc.

    K Number Device Name
    K072421 K-Y BRAND YOURS+MINE
    K072360 K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
    K062535 K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
    K053397 K-Y BRAND SENSUAL MIST
    K023789 O.B. TAMPONS