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

    RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)

    K Number: K955671 · Decision Mar 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    8
    Review Days
    93

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    Basic Information

    Device Name
    RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
    K Number
    K955671
    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
    December 4, 1995
    Decision Date
    March 6, 1996
    Product Code
    OKS
    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
    OKS Lacrimal Stents And Intubation Sets

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    Other Clearances by G.W.B. Intl., Ltd.

    K Number Device Name
    K954094 OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
    K950569 OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    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