Your submission must include the following:

1. (a) Organizational/administrative information:

   1. (1) Your name and address;
   2. (2) Generic and trade names of your device;
   3. (3) Name and address of the contact person for the submission;
   4. (4) Premarket application/submission number and device identifiers for your device;
   5. (5) Table of contents identifying the page numbers for each section of the submission;
   6. (6) Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);
   7. (7) Product codes and a list of all relevant model numbers; and
   8. (8) Indications for use and claims for the device;
2. (b) Postmarket surveillance plan;

3. (c) Designated person information;

   1. (1) Name, address, and telephone number; and
   2. (2) Experience and qualifications.

[67 FR 38887, June 6, 2002, as amended at 78 FR 58823, Sept. 24, 2013]