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

    UNIQUET

    K Number: K931198 · Decision Sep 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    335
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    176

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    Basic Information

    Device Name
    UNIQUET
    K Number
    K931198
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Icat Systems
    Date Received
    March 9, 1993
    Decision Date
    September 1, 1993
    Product Code
    GAX
    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
    GAX Tourniquet, Nonpneumatic

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