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 |