BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    GLUSEAL 90, MODEL GLU9010

    K Number: K083752 · Decision Feb 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    5
    Review Days
    68

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    Basic Information

    Device Name
    GLUSEAL 90, MODEL GLU9010
    K Number
    K083752
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Glustitch, Inc.
    Date Received
    December 17, 2008
    Decision Date
    February 23, 2009
    Product Code
    KMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KMF Bandage, Liquid

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