The following data is part of a premarket notification filed by Aok Tooling Limited with the FDA for Plain Surgical Mask.
| Device ID | K201517 |
| 510k Number | K201517 |
| Device Name: | Plain Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | AOK Tooling Limited #8, Longtian 3Rd, Longtian Street, Pingshan Dist. Shenzhen, CN 518122 |
| Contact | Francis Nithyananthan |
| Correspondent | Paul Dryden AOK Tooling Limited% ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-09-04 |