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510(k) Data Aggregation

    K Number
    K963777
    Device Name
    HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
    Date Cleared
    1997-07-28

    (311 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    STEPHENSON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - VENOUS STASIS S - DECUBITUS STASIS UL CERS - DIABETIC ULCERS - вики с - FROSTBITE -POST SURGICAL WOUNDS
    Device Description
    Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100
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