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

    DUREX SYNTHETIC POLYISOPRENE MALE CONDOM

    K Number: K072169 · Decision Jun 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    318

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    Basic Information

    Device Name
    DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
    K Number
    K072169
    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
    August 6, 2007
    Decision Date
    June 19, 2008
    Product Code
    MOL
    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
    MOL Condom, Synthetic

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    Other Clearances by Ssl Americas, Inc.

    K Number Device Name
    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
    K020659 DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT