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

    OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

    K Number: K911108 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    38
    Same Product Code
    48
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
    K Number
    K911108
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    G.W.B. Intl., Ltd.
    Date Received
    March 4, 1991
    Decision Date
    May 13, 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 G.W.B. Intl., Ltd.

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    K950569 OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    K940508 OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
    K911110 OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
    K911109 OPHTA SIL (R), LACHRYMAL INTUBATION SETS
    K896029 DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20