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

    DUREX PLAY TINGLING LUBRICANT

    K Number: K042958 · Decision Apr 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    10
    Review Days
    163

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    Basic Information

    Device Name
    DUREX PLAY TINGLING LUBRICANT
    K Number
    K042958
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ssl Americas, Inc.
    Date Received
    October 27, 2004
    Decision Date
    April 8, 2005
    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 Ssl Americas, Inc.

    K Number Device Name
    K072169 DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
    K063385 DUREX PLAY MASSAGE GEL LUBRICANT
    K060098 DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
    K042470 DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
    K042563 DUREX PLAY WARMER LUBRICANT
    K032227 DUREX FLAVORED LATEX CONDOM
    K040353 FLIGHT SOCK
    K032124 DUREX PLAY LUBRICANT
    K020659 DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT