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

    DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

    K Number: K020659 · Decision Mar 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    398
    Applicant Total
    10
    Review Days
    28

    Basic Information

    Device Name
    DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
    K Number
    K020659
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SSL AMERICAS, INC.
    Date Received
    March 1, 2002
    Decision Date
    March 29, 2002
    Product Code
    HIS
    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
    HIS Condom

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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
    K042958 DUREX PLAY TINGLING LUBRICANT
    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