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

    FLORASEAL, MODEL FS350D

    K Number: K083354 · Decision Jul 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    249

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    Basic Information

    Device Name
    FLORASEAL, MODEL FS350D
    K Number
    K083354
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adhezion Biomedical
    Date Received
    November 13, 2008
    Decision Date
    July 20, 2009
    Product Code
    NZP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZP Sealant, Microbial

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    Other Clearances by Adhezion Biomedical

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