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

    WET-STOP

    K Number: K842547 · Decision Oct 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    36
    Applicant Total
    9
    Review Days
    109

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    Basic Information

    Device Name
    WET-STOP
    K Number
    K842547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.2040
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Palco Laboratories, Inc.
    Date Received
    July 2, 1984
    Decision Date
    October 19, 1984
    Product Code
    KPN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KPN Alarm, Conditioned Response Enuresis

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    K904988 PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
    K872233 INJECT-EASE
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