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

    CLOSED FOLEY CATHETER SYSTEM

    K Number: K873288 · Decision Nov 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    102

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    Basic Information

    Device Name
    CLOSED FOLEY CATHETER SYSTEM
    K Number
    K873288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Todd Medical, Inc.
    Date Received
    August 17, 1987
    Decision Date
    November 27, 1987
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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