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510(k) Data Aggregation

    K Number
    K022584
    Device Name
    CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
    Manufacturer
    CARDIOTECH INTL.
    Date Cleared
    2002-12-30

    (147 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOTECH INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full- thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites
    Device Description
    CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive, and absorptive. The wound contact surface is composed of an antibiotic containing hydrogel. The OTC antibiotic mixture used consists of the following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. A second outer layer consists of a polymeric film.
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