The following data is part of a premarket notification filed by Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi with the FDA for Myflon Surgical Mask Level 3.
| Device ID | K212111 |
| 510k Number | K212111 |
| Device Name: | Myflon Surgical Mask Level 3 |
| Classification | Mask, Surgical |
| Applicant | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi Ve TIC A.S. Eskisehir Industrial Zone 26th Street No 9 Eskisehir, TR 26100 |
| Contact | Ali Serdar Serteser |
| Correspondent | W. Victoria Rogers Rogers Consulting 11110 Arranmore Cove Roanoke, IN 46783 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-06 |
| Decision Date | 2022-01-23 |