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

    SEPACELL R-500 AND SEPACELL R-500A

    K Number: K873792 · Decision Jan 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    13
    Review Days
    124

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    Basic Information

    Device Name
    SEPACELL R-500 AND SEPACELL R-500A
    K Number
    K873792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Advocacy International, Ltd.
    Date Received
    September 17, 1987
    Decision Date
    January 19, 1988
    Product Code
    CAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAK Microfilter, Blood Transfusion

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    Other Clearances by Advocacy International, Ltd.

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    K854259 SEPACELL R-500 & SEPACELL R-500A
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    K830183 ASAHI HOLLOW FIBER KIDNEYS NR SERIES
    K830231 ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES
    K823733 EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR
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