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

    POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER

    K Number: K862124 · Decision Aug 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    236
    Applicant Total
    2
    Review Days
    72

    Basic Information

    Device Name
    POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER
    K Number
    K862124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    POLYMED LABORATORIES
    Date Received
    June 3, 1986
    Decision Date
    August 14, 1986
    Product Code
    KOD
    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
    KOD Catheter, Urological

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