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

    SPINAL NEEDLE

    K Number: K960405 · Decision Feb 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    18
    Review Days
    30

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    Basic Information

    Device Name
    SPINAL NEEDLE
    K Number
    K960405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promex, Inc.
    Date Received
    January 29, 1996
    Decision Date
    February 28, 1996
    Product Code
    MIA
    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
    MIA Needle, Spinal, Short Term

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