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

    DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL

    K Number: K960815 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    13
    Review Days
    61

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    Basic Information

    Device Name
    DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
    K Number
    K960815
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dumex Medical Surgical Products, Ltd.
    Date Received
    February 28, 1996
    Decision Date
    April 29, 1996
    Product Code
    NAD
    Advisory Committee
    General, Plastic Surgery
    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
    NAD Dressing, Wound, Occlusive

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    K980863 DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
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