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

    NATURALYTE MIXER

    K Number: K883408 · Decision Oct 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    62
    Review Days
    81

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    Basic Information

    Device Name
    NATURALYTE MIXER
    K Number
    K883408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    National Medical Care, Medical Products Div., Inc.
    Date Received
    August 11, 1988
    Decision Date
    October 31, 1988
    Product Code
    FIN
    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
    FIN Tank, Holding, Dialysis

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    K920797 HEMODIALYSIS BLOOD TUBING SET
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