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§ 822.9 - What must I include in my submission?

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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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§ 822.8 - When, where, and how must I submit my postmarket surveillance plan?
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§ 822.10 - What must I include in my surveillance plan?