BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇨🇦 Canada

    THALAFIX NATURAL SEA SALT DRESSING

    K Number: K980779 · Decision Jun 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    13
    Review Days
    116

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THALAFIX NATURAL SEA SALT DRESSING
    K Number
    K980779
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Dumex Medical Surgical Products, Ltd.
    Date Received
    March 2, 1998
    Decision Date
    June 26, 1998
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KMF), ordered by most recent decision date.

    TearRepair Liquid Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Rochal Bioshield Silicone Film

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Aleo BME Liquid Bandage

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Cavilon Advanced High Endurance Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Atteris No-Sting Skin Protectant

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    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
    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. →