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

    OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}

    K Number: K950569 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    38
    Same Product Code
    48
    Applicant Total
    8
    Review Days
    41

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    Basic Information

    Device Name
    OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    K Number
    K950569
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    G.W.B. Intl., Ltd.
    Date Received
    February 1, 1995
    Decision Date
    March 14, 1995
    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.

    K Number Device Name
    K955671 RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
    K954094 OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
    K940508 OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
    K911110 OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
    K911108 OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
    K911109 OPHTA SIL (R), LACHRYMAL INTUBATION SETS
    K896029 DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20