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

    8810 PUMP-PUMP SINGLE NEEDLE DEVICE

    K Number: K873279 · Decision Oct 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    11
    Review Days
    67

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    Basic Information

    Device Name
    8810 PUMP-PUMP SINGLE NEEDLE DEVICE
    K Number
    K873279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cd Medical, Inc.
    Date Received
    August 17, 1987
    Decision Date
    October 23, 1987
    Product Code
    FIF
    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
    FIF Set, Dialysis, Single Needle With Uni-Directional Pump

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