The following data is part of a premarket notification filed by Amphastar Nanjing Pharmaceuticals, Inc. with the FDA for Surgical Face Mask.
| Device ID | K201545 |
| 510k Number | K201545 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Amphastar Nanjing Pharmaceuticals, Inc. No.5 Xinghe Road, Nanjing Economic And Technological Development Zone Nanjing, CN 210038 |
| Contact | Bob Bao |
| Correspondent | Bob Bao Amphastar Nanjing Pharmaceuticals, Inc. No.5 Xinghe Road, Nanjing Economic And Technological Development Zone Nanjing, CN 210038 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-09 |
| Decision Date | 2021-02-12 |