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Kit Certification for 510(k)s

            Kit Certification for 510(k)s

For review purposes of a premarket notification (510(k)) for a
kit, please provide the certification stated below:

    I certify that the following components of my kit are either
    (1) legally marketed pre-Amendments devices, (2) exempt from
    premarket notification (consistent with the exemption
    criteria described in the classification regulation(s) and
    the limitation of exemptions for Section 510(k) of the act
    (e.g., 862.9), or (3) have been found to be substantially
    equivalent through the premarket notification process for
    the use(s) for which the kit is to be intended (i.e., I am
    not claiming or causing a new use for the component(s)).

    I further certify that these components are not purchased in
    "bulk", but are purchased in finished form, i.e., they are
    packaged, labeled, etc., consistent with their pre-Amendments, 
    exemption, or premarket notification criteria and status.

If you cannot make the above referenced certification statements for each 
component of your kit, you must itemize the components without a pre-Amendments 
exemption, or premarket notification status.  In this case we will continue our 
premarket notification review of these components of your kit.

If you cannot make the above referenced statement in the second paragraph for 
each component of your kit, you must itemize these components, state whether 
they are pre-Amendments, exempt, or have been found substantially equivalent 
through the premarket notification process, and describe how you further 
process them (e.g., sterilize, package/repackage, label/relabel, etc.).

Updated September 5, 1997

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