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

    PDO Absorbable Punctum Plug

    K Number: K150288 · Decision Aug 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    39
    Same Product Code
    48
    Applicant Total
    10
    Review Days
    204

    Basic Information

    Device Name
    PDO Absorbable Punctum Plug
    K Number
    K150288
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    RIVERPOINT MEDICAL
    Date Received
    February 5, 2015
    Decision Date
    August 28, 2015
    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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