Your submission must include the following:
Organizational/administrative information:
Your name and address;
Generic and trade names of your device;
Name and address of the contact person for the submission;
Premarket application/submission number and device identifiers for your device;
Table of contents identifying the page numbers for each section of the submission;
Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);
Product codes and a list of all relevant model numbers; and
Indications for use and claims for the device;
Postmarket surveillance plan;
Designated person information;
Name, address, and telephone number; and
Experience and qualifications.
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