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

    PULM O2 SUCTION CATHETER TRAYS

    K Number: K953226 · Decision Aug 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    9
    Review Days
    33

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    Basic Information

    Device Name
    PULM O2 SUCTION CATHETER TRAYS
    K Number
    K953226
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Premium Plastics, Inc.
    Date Received
    July 6, 1995
    Decision Date
    August 8, 1995
    Product Code
    BSY
    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
    BSY Catheters, Suction, Tracheobronchial

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