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

    GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

    K Number: K933818 · Decision Jan 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    11
    Review Days
    539

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    Basic Information

    Device Name
    GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
    K Number
    K933818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    C.G.H. Medical, Inc.
    Date Received
    August 4, 1993
    Decision Date
    January 25, 1995
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by C.G.H. Medical, Inc.

    K Number Device Name
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    K931720 LUNDIA ALPHA 700 HEMODIALYZER
    K924437 HEMOSPAL KIT B22 / MULTIFLOW 60 KIT
    K940601 GAMBRO BICART 720G
    K915154 GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
    K914271 GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
    K915504 GAMBRO LUNDIA ALPHA HEMODIALYZERS
    K911603 HEMOSPAL KIT B22
    Search all 11 clearances from C.G.H. Medical, Inc. →