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

    HEMO-BARRIER TOURNIQUET

    K Number: K950258 · Decision Jun 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    HEMO-BARRIER TOURNIQUET
    K Number
    K950258
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemo-Barrier Technologies, Inc.
    Date Received
    January 23, 1995
    Decision Date
    June 19, 1995
    Product Code
    EFQ
    Advisory Committee
    Unknown
    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
    EFQ Gauze/Sponge, Internal

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