How do I “Bundle” 510(k) submissions using the CeSub eSubmitter software?
In section 1.0 of the Admin tab, the software asks you “Is this a bundled submission?” You must answer “Yes” to this question in order to bundle your 510(k) submission. When completing the submission it is important to identify which assay is being referred to when responding to questions, i.e. answer the question for each assay separately but in the same text response box.
