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

    16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE

    K Number: K894878 · Decision Nov 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    151
    Applicant Total
    10
    Review Days
    121

    Basic Information

    Device Name
    16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
    K Number
    K894878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    R. J. DOYLE, INC.
    Date Received
    August 1, 1989
    Decision Date
    November 30, 1989
    Product Code
    BSP
    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
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by R. J. DOYLE, INC.

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    K894873 16 GA X 10 BULLET POINT NEEDLE
    K894872 16 GA X 6 BULLET POINT NEEDLE
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