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

    PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM

    K Number: K881514 · Decision Jun 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
    K Number
    K881514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5750
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hall Laboratories, Inc.
    Date Received
    April 11, 1988
    Decision Date
    June 16, 1988
    Product Code
    BSK
    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
    BSK Cuff, Tracheal Tube, Inflatable

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    Other Clearances by Hall Laboratories, Inc.

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    K874645 CLOSED WOUND DRAINAGE SYSTEMS