The following data is part of a premarket notification filed by Danameco Medical Joint Stock Corporation with the FDA for D-care Surgical Face Mask 3 Ply, D-care Medical Face Mask 3 Ply.
| Device ID | K213970 |
| 510k Number | K213970 |
| Device Name: | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply |
| Classification | Mask, Surgical |
| Applicant | Danameco Medical Joint Stock Corporation No 12, Trinh Cong Son Street Da Nang, VN 550000 |
| Contact | Huynh Thi Li Li |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-01-23 |