BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇱 Israel

    WoundClot9

    K Number: K160679 · Decision Aug 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    1
    Review Days
    151

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    Basic Information

    Device Name
    WoundClot9
    K Number
    K160679
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Core Scientific Creation , Ltd.
    Date Received
    March 10, 2016
    Decision Date
    August 8, 2016
    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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