The following data is part of a premarket notification filed by Taiji Medical Supplies, Inc. with the FDA for Taiji Professional Series Level 3 Surgical Face Mask.
| Device ID | K211861 |
| 510k Number | K211861 |
| Device Name: | TAIJI Professional Series Level 3 Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Taiji Medical Supplies, Inc. 3211 Progress Drive Lincolnton, NC 28092 |
| Contact | Katherine Giannamore |
| Correspondent | Abdel B Halim Global Quality And Regulatory Services 10 Scenic Way Monroe, NJ 08831 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2021-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860007355902 | K211861 | 000 |