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

    SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)

    K Number: K963570 · Decision Oct 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    5
    Applicant Total
    22
    Review Days
    43

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    Basic Information

    Device Name
    SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
    K Number
    K963570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Industries Medical Systems, Inc.
    Date Received
    September 5, 1996
    Decision Date
    October 18, 1996
    Product Code
    FMJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMJ Manometer, Spinal-Fluid

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    Other Clearances by Smiths Industries Medical Systems, Inc.

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