21 CFR §822.9

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.