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

    EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG

    K Number: K905427 · Decision Jun 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    39
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    184

    Basic Information

    Device Name
    EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
    K Number
    K905427
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    EAGLE VISION, INC.
    Date Received
    December 4, 1990
    Decision Date
    June 6, 1991
    Product Code
    LZU
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LZU Plug, Punctum

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    Other Clearances by EAGLE VISION, INC.

    K Number Device Name
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    K991130 FLEXPLUG
    K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
    K890920 EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
    K883233 EV MONOCANALICULAR STENT (TM)