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

    ADVANCED TRAUMA DRESSING (ATD)

    K Number: K101257 · Decision Dec 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    1
    Review Days
    576

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    Basic Information

    Device Name
    ADVANCED TRAUMA DRESSING (ATD)
    K Number
    K101257
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosys, Inc.
    Date Received
    May 4, 2010
    Decision Date
    December 1, 2011
    Product Code
    QSY
    Advisory Committee
    Unknown
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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