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

    TRACH CLEANING TRAY

    K Number: K811990 · Decision Jul 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    391
    Registration Numbers
    392
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    14

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    Basic Information

    Device Name
    TRACH CLEANING TRAY
    K Number
    K811990
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5300
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Associated Medical Products Co.
    Date Received
    July 13, 1981
    Decision Date
    July 27, 1981
    Product Code
    FRL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRL Fiber, Medical, Absorbent

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