The following data is part of a premarket notification filed by Filligent Limited with the FDA for Biofriend Biomask N95 Surgical Respirator.
| Device ID | K122702 |
| 510k Number | K122702 |
| Device Name: | BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR |
| Classification | N95 Respirator With Antimicrobial/antiviral Agent |
| Applicant | FILLIGENT LIMITED 7TH FLLOR, 69 JERVOIS STREET, SHEUNG WAN Hong Kong, CN Hk |
| Contact | Kai Deusch |
| Correspondent | Kai Deusch FILLIGENT LIMITED 7TH FLLOR, 69 JERVOIS STREET, SHEUNG WAN Hong Kong, CN Hk |
| Product Code | ONT |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2013-03-18 |
| Summary: | summary |