BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DUREX PLAY WARMER LUBRICANT

    K Number: K042563 · Decision Feb 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    10
    Review Days
    155

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    Basic Information

    Device Name
    DUREX PLAY WARMER LUBRICANT
    K Number
    K042563
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ssl Americas, Inc.
    Date Received
    September 21, 2004
    Decision Date
    February 23, 2005
    Product Code
    KMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KMJ Lubricant, Patient

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    Other Clearances by Ssl Americas, Inc.

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    K032227 DUREX FLAVORED LATEX CONDOM
    K040353 FLIGHT SOCK
    K032124 DUREX PLAY LUBRICANT
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