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

    HEMCON CHITOFLEX-SURGICAL DRESSING

    K Number: K071519 · Decision Aug 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    5
    Review Days
    63

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    Basic Information

    Device Name
    HEMCON CHITOFLEX-SURGICAL DRESSING
    K Number
    K071519
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemcon, Inc.
    Date Received
    June 4, 2007
    Decision Date
    August 6, 2007
    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, Inc.

    K Number Device Name
    K060363 HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
    K043050 HEMCON BANDAGE AND HEMCON BANDAGE OTC
    K030946 HEMCON BANDAGE OTC; HEMCON CATH/AID
    K023298 HEMCON BANDAGE