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

    DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL

    K Number: K980861 · Decision May 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    13
    Review Days
    76

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    Basic Information

    Device Name
    DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
    K Number
    K980861
    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
    March 5, 1998
    Decision Date
    May 20, 1998
    Product Code
    MGQ
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Dumex Medical Surgical Products, Ltd.

    K Number Device Name
    K992732 STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
    K993119 STERILE HYDROGEL
    K990332 DUMEX IODOFORM PACKING STRIP
    K980779 THALAFIX NATURAL SEA SALT DRESSING
    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
    K946326 DUTEX GAUZE BANDAGE
    Search all 13 clearances from Dumex Medical Surgical Products, Ltd. →