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

    PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING

    K Number: K944429 · Decision Nov 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    183
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
    K Number
    K944429
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5240
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precision Thermoplastic Components, Inc.
    Date Received
    September 12, 1994
    Decision Date
    November 18, 1994
    Product Code
    CAI
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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    Other Clearances by Precision Thermoplastic Components, Inc.

    K Number Device Name
    K943874 PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS