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

    NEO-CARE LUMBER PUNCTURE KIT

    K Number: K970997 · Decision May 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    NEO-CARE LUMBER PUNCTURE KIT
    K Number
    K970997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Klein-Baker Medical, Inc.
    Date Received
    March 19, 1997
    Decision Date
    May 22, 1997
    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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    Other Clearances by Klein-Baker Medical, Inc.

    K Number Device Name
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