BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    Lubricating Jelly

    K Number: K142473 · Decision Apr 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    222

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    Basic Information

    Device Name
    Lubricating Jelly
    K Number
    K142473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sion Biotext Medical , Ltd.
    Date Received
    September 3, 2014
    Decision Date
    April 13, 2015
    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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