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

    SEREINE EXTRA STRENGTH DAILY CLEANER

    K Number: K011561 · Decision Nov 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    119
    Applicant Total
    1
    Review Days
    183

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    Basic Information

    Device Name
    SEREINE EXTRA STRENGTH DAILY CLEANER
    K Number
    K011561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilsa, Inc.
    Date Received
    May 21, 2001
    Decision Date
    November 20, 2001
    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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