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

    STERILE HYDROGEL

    K Number: K993119 · Decision Nov 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    13
    Review Days
    64

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    Basic Information

    Device Name
    STERILE HYDROGEL
    K Number
    K993119
    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
    September 20, 1999
    Decision Date
    November 23, 1999
    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
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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
    K946326 DUTEX GAUZE BANDAGE
    Search all 13 clearances from Dumex Medical Surgical Products, Ltd. →