BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    QC CAP

    K Number: K945567 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    4
    Review Days
    133

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    Basic Information

    Device Name
    QC CAP
    K Number
    K945567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medionics International, Inc.
    Date Received
    September 27, 1994
    Decision Date
    February 7, 1995
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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    Other Clearances by Medionics International, Inc.

    K Number Device Name
    K130441 FALLER STYLET
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