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

    LUBRICATING JELLY, LOW VISCOSITY

    K Number: K961502 · Decision Jul 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    48
    Applicant Total
    19
    Review Days
    90

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    Basic Information

    Device Name
    LUBRICATING JELLY, LOW VISCOSITY
    K Number
    K961502
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Span-America Medical Systems, Inc.
    Date Received
    April 19, 1996
    Decision Date
    July 18, 1996
    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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