Section 822.9 - What must I include in my submission?Your submission must include the following:
(a) Organizational/administrative information:(1) Your name and address;(2) Generic and trade names of your device;(3) Name and address of the contact person for the submission;(4) Premarket application/submission number and device identifiers for your device;(5) Table of contents identifying the page numbers for each section of the submission;(6) Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);(7) Product codes and a list of all relevant model numbers; and(8) Indications for use and claims for the device;(b) Postmarket surveillance plan;(c) Designated person information;(1) Name, address, and telephone number; and(2) Experience and qualifications. 67 FR 38887 , June 6, 2002, as amended at 78 FR 58823 , Sept. 24, 2013