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

    MACROPORE SURGICAL BARRIER FILM

    K Number: K023643 · Decision Feb 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    17
    Review Days
    114

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    Basic Information

    Device Name
    MACROPORE SURGICAL BARRIER FILM
    K Number
    K023643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3320
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macropore Biosurgery, Inc.
    Date Received
    October 30, 2002
    Decision Date
    February 21, 2003
    Product Code
    MTZ
    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
    MTZ Wrap, Implant, Orbital

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