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

    UNICOR, INC. CORRUGATED TUBING

    K Number: K953784 · Decision Sep 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    UNICOR, INC. CORRUGATED TUBING
    K Number
    K953784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unicor, Inc.
    Date Received
    August 14, 1995
    Decision Date
    September 19, 1995
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

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    Other Clearances by Unicor, Inc.

    K Number Device Name
    K953786 UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
    K953787 UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
    K953788 UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
    K953785 UNICOR, INC. VENTILATOR HOSES