I have a question regarding the openFDA 510k data:
According to the File Layout for Releasable 510(k)s the
statement_or_summary entry gives following information:
SUMMARY indicates that a summary of safety and effectiveness information is available from FDA
However, for many devices with a summary entry in
statement_or_summary, no summary document is available on the 510(k) Premarket Notification Database: e.g., for K990380
Where are these summary documents available?