BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS

    K Number: K883748 · Decision Jan 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    18
    Review Days
    152

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    Basic Information

    Device Name
    RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS
    K Number
    K883748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kawasumi Laboratories Co., Ltd.
    Date Received
    September 1, 1988
    Decision Date
    January 31, 1989
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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    K935514 VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
    K935506 MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION
    K935505 WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER
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    K921902 PORT ACCESS NEEDLE
    K923323 INTERMITTENT INJECTION SITE
    Search all 18 clearances from Kawasumi Laboratories Co., Ltd. →