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

    IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)

    K Number: K873287 · Decision Nov 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)
    K Number
    K873287
    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 13, 1987
    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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    Other Clearances by Todd Medical, Inc.

    K Number Device Name
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    K850646 ECLIPSE SELF ADHERING ELECTRODE
    K850004 TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF