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

    SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES

    K Number: K071203 · Decision Jun 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
    K Number
    K071203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optikem International, Inc.
    Date Received
    May 1, 2007
    Decision Date
    June 13, 2007
    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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    Other Clearances by Optikem International, Inc.

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