BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    STERILE WATER & STERILE 0.9% SODIUM CHLORIDE

    K Number: K992732 · Decision Apr 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    13
    Review Days
    251

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    Basic Information

    Device Name
    STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
    K Number
    K992732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dumex Medical Surgical Products, Ltd.
    Date Received
    August 13, 1999
    Decision Date
    April 20, 2000
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Dumex Medical Surgical Products, Ltd.

    K Number Device Name
    K993119 STERILE HYDROGEL
    K990332 DUMEX IODOFORM PACKING STRIP
    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. →