The following data is part of a premarket notification filed by Remade Usa Llc with the FDA for Surgical Mask.
| Device ID | K212451 |
| 510k Number | K212451 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | ReMade USA LLC 2915 E Washington Blvd Los Angeles, CA 90023 |
| Contact | David Durst |
| 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 | 2021-08-05 |
| Decision Date | 2021-09-10 |