BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    MaxiTears Contacts PF

    K Number: K182984 · Decision Jul 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    268

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    Basic Information

    Device Name
    MaxiTears Contacts PF
    K Number
    K182984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5918
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnivision AG
    Date Received
    October 29, 2018
    Decision Date
    July 24, 2019
    Product Code
    MRC
    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
    MRC Products, Contact Lens Care, Rigid Gas Permeable

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