BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF

    K Number: K953953 · Decision Sep 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    33
    Applicant Total
    91
    Review Days
    38

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    Basic Information

    Device Name
    DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
    K Number
    K953953
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deroyal Industries, Inc.
    Date Received
    August 22, 1995
    Decision Date
    September 29, 1995
    Product Code
    KCY
    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
    KCY Tourniquet, Pneumatic

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