BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION

    K Number: K994021 · Decision Feb 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
    K Number
    K994021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Strieter Clinical Research Laboratories, Inc.
    Date Received
    November 26, 1999
    Decision Date
    February 22, 2000
    Product Code
    LYL
    Advisory Committee
    Ophthalmic
    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
    LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

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