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 |