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

    MODIFIED DECANNULATION STOPPER

    K Number: K894050 · Decision Aug 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    3
    Review Days
    55

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    Basic Information

    Device Name
    MODIFIED DECANNULATION STOPPER
    K Number
    K894050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Premier Medical
    Date Received
    June 7, 1989
    Decision Date
    August 1, 1989
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Premier Medical

    K Number Device Name
    K896303 BIOPSY PUNCH
    K884418 PREMIER DIE-TRAK ARTICULATOR