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

    HYDROGEL CANALICULAR PLUG

    K Number: K040912 · Decision Nov 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    38
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    222

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    Basic Information

    Device Name
    HYDROGEL CANALICULAR PLUG
    K Number
    K040912
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Partners IN Biomaterials, Inc.
    Date Received
    April 8, 2004
    Decision Date
    November 16, 2004
    Product Code
    LZU
    Advisory Committee
    Unknown
    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
    LZU Plug, Punctum

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