The following data is part of a premarket notification filed by Banyan Usa Llc with the FDA for Banyan Usa Surgical Mask Level 3.
| Device ID | K211097 |
| 510k Number | K211097 |
| Device Name: | Banyan USA Surgical Mask Level 3 |
| Classification | Mask, Surgical |
| Applicant | Banyan USA LLC 390 Oser Avenue Hauppauge, NY 11788 |
| Contact | Ricardo Ryan |
| Correspondent | Timothy Kania MDI Consultants Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2021-09-22 |