1

Medical Device User Fee Cover Sheet

2

CDRH Premarket Review Submission Cover Sheet

3

510(k) Cover Letter

4

Indications for Use Statement

5

510(k) Summary or 510(k) Statement

6

Truthful and Accuracy Statement

7

Financial Certification or Disclosure Statement

8

Declarations of Conformity and Summary Reports

9

Executive Summary

10

Device Description

11

Substantial Equivalence Discussion

12

Proposed Labeling

13

Shelf Life

14

Biocompatibility

15

Software

16

Electromagnetic Compatibility and Electrical Safety

17

Performance Testing – Bench

18

Performance Testing – Animal

19

Performance Testing – Clinical

20

Certification of Compliance with ClinicalTrials.gov Data Bank

21

Other