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

    TENCKHOFF PERITONEAL DIALYSIS KIT

    K Number: K902203 · Decision Aug 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    36
    Review Days
    77

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    Basic Information

    Device Name
    TENCKHOFF PERITONEAL DIALYSIS KIT
    K Number
    K902203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Akcess Medical Products, Inc.
    Date Received
    May 16, 1990
    Decision Date
    August 1, 1990
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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