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

    IN A WINK LUBRICATING & REWETTING DROPS

    K Number: K853445 · Decision Nov 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    IN A WINK LUBRICATING & REWETTING DROPS
    K Number
    K853445
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Ciba Vision Care
    Date Received
    August 16, 1985
    Decision Date
    November 29, 1985
    Product Code
    HPX
    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
    HPX Lens, Contact (Polymethylmethacrylate)

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    Other Clearances by Ciba Vision Care

    K Number Device Name
    K863346 PROFESSIONAL DISINFECTION SYSTEM (PDS)