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

    AK-10

    K Number: K771227 · Decision Aug 2, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    86
    Review Days
    26

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    Basic Information

    Device Name
    AK-10
    K Number
    K771227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gambro, Inc.
    Date Received
    July 7, 1977
    Decision Date
    August 2, 1977
    Product Code
    FIL
    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
    FIL System, Dialysate Delivery, Single Pass

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