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

    BPZ02 MULTIPURPOSE SOLUTION

    K Number: K083757 · Decision Nov 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    21
    Applicant Total
    92
    Review Days
    336

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    Basic Information

    Device Name
    BPZ02 MULTIPURPOSE SOLUTION
    K Number
    K083757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb, Inc.
    Date Received
    December 17, 2008
    Decision Date
    November 18, 2009
    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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