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K13 1941 MAY 1.5 2fl14 Additional In format on 11for K 131941 Exhibit42 510(k) Summary Page I of 6 Project h: M0212013A Exhibit #2 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness
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What is additional information?
Additional information refers to any extra details or data that need to be provided on top of the standard information.
Who is required to file additional information?
Individuals or entities who are requested to provide more information beyond the usual requirements may be required to file additional information.
How to fill out additional information?
Additional information can typically be filled out using the forms or documents provided by the requesting party, following any specific instructions or guidelines given.
What is the purpose of additional information?
The purpose of providing additional information is to ensure that all necessary details are disclosed and to provide a more comprehensive picture or context for a particular situation or request.
What information must be reported on additional information?
The specific information that must be reported on additional information will vary depending on the requirements or requests made by the party requesting the additional information.
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