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

    OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION

    K Number: K112909 · Decision Apr 30, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    92
    Review Days
    210

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    Basic Information

    Device Name
    OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
    K Number
    K112909
    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
    October 3, 2011
    Decision Date
    April 30, 2012
    Product Code
    LPN
    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
    LPN Accessories, Soft Lens Products

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