1. Medical Device User Fee Cover Sheet (Form FDA 3601)医疗器械使用者费（注册费）首页，即向FDA付款后收到的付款证明

2. CDRH Premarket Review Submission Cover Sheet    (CDRH: Center for Devices and Radiological Health器械与辐射健康中心) CDRH上市前审查递交文件封面

3. 510(k) Cover Letter   510(k)附信

4. Indications for Use Statement 适用范围声明

5. 510(k) Summary or 510(k) Statement  510(k)概要或声明

6. Truthful and Accuracy Statement   真实性和准确性声明

7. Class III Summary and Certification  III类产品概要和证书（不适用）

8. Financial Certification or Disclosure Statement 财务公开声明

9. Declarations of Conformity and Summary Reports 一致性声明和综合报告

10. Executive Summary  摘要

11. Device Description   设备描述

12. Substantial Equivalence Discussion  实质等同报告

13. Proposed Labeling   产品标签

14. Sterilization and Shelf Life   灭菌和货架寿命

15. Biocompatibility      生物兼容性报告

16. Software     软件验证报告

17. Electromagnetic Compatibility and Electrical Safety  电磁兼容和电气安全测试报告

18. Performance Testing – Bench 性能测试-工作台

19. Performance Testing – Animal 性能测试-动物

20. Performance Testing – Clinical 性能测试-临床

21. Other   其他