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

    INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200

    K Number: K052870 · Decision Sep 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    3
    Applicant Total
    104
    Review Days
    353

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    Basic Information

    Device Name
    INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
    K Number
    K052870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark Corp.
    Date Received
    October 11, 2005
    Decision Date
    September 29, 2006
    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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