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

    DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9

    K Number: K920693 · Decision Sep 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    62
    Review Days
    220

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    Basic Information

    Device Name
    DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
    K Number
    K920693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Medical Care, Medical Products Div., Inc.
    Date Received
    February 14, 1992
    Decision Date
    September 21, 1992
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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    K920697 DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP
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