BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEBELER SAFE-T-TUBE

    K Number: K960450 · Decision Apr 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    236
    Applicant Total
    33
    Review Days
    80

    Basic Information

    Device Name
    HEBELER SAFE-T-TUBE
    K Number
    K960450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON MEDICAL PRODUCTS, INC.
    Date Received
    January 30, 1996
    Decision Date
    April 19, 1996
    Product Code
    BTR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTR Tube, Tracheal (W/Wo Connector)

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