K212111 is an FDA 510(k) clearance for the Myflon Surgical Mask Level 3. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi (Eskisehir, TR). The FDA issued a Cleared decision on January 23, 2022, 201 days after receiving the submission on July 6, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2021 |
| Decision Date | January 23, 2022 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |