BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    DUTEX GAUZE BANDAGE

    K Number: K946326 · Decision Jan 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    13
    Review Days
    33

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    Basic Information

    Device Name
    DUTEX GAUZE BANDAGE
    K Number
    K946326
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dumex Medical Surgical Products, Ltd.
    Date Received
    December 22, 1994
    Decision Date
    January 24, 1995
    Product Code
    EFQ
    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
    EFQ Gauze/Sponge, Internal

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    K980779 THALAFIX NATURAL SEA SALT DRESSING
    K980861 DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
    K980863 DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
    K980777 DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
    K980791 DUMEX PAK-ITS WOVEN RIBBON PACKING
    K960815 DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
    K950132 DUMEX WET DRESSINGS
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