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

    LUBRICATING JELLY

    K Number: K871169 · Decision Apr 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    48
    Applicant Total
    5
    Review Days
    8

    Basic Information

    Device Name
    LUBRICATING JELLY
    K Number
    K871169
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    H & P INDUSTRIES, INC.
    Date Received
    March 24, 1987
    Decision Date
    April 1, 1987
    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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