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

    HEMCON HEMOSTATIC GEL

    K Number: K112215 · Decision Apr 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    3
    Review Days
    254

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    Basic Information

    Device Name
    HEMCON HEMOSTATIC GEL
    K Number
    K112215
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemcon Medical Technologies Europe, Ltd.
    Date Received
    August 2, 2011
    Decision Date
    April 12, 2012
    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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    Other Clearances by Hemcon Medical Technologies Europe, Ltd.

    K Number Device Name
    K121485 GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
    K093729 GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I