It is important not to overlook the obvious. Proper identification is crucial. Be sure that the applicant’s name and street address are included; do not use a post office box. Telephone and fax numbers should be included for the contact person, and if that person is not the applicant, special note of that fact should be made. Be sure the applicant signs the submission and that the date of the application is noted.
Include a table of contents with page numbers indicating the location of the truth-and – accuracy statement; the 510(k) summary or statement; and any attachments, appendices, or illustrations. Be also sure to include the addresses of manufacturing and sterilizing sites.