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

    TUBE, HEAVY GLASS WALL INJECTION

    K Number: K760500 · Decision Sep 3, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    TUBE, HEAVY GLASS WALL INJECTION
    K Number
    K760500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1660
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Unimetrics Corp.
    Date Received
    August 23, 1976
    Decision Date
    September 3, 1976
    Product Code
    DXL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXL Injector, Indicator

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