The following data is part of a premarket notification filed by Filligent Limited with the FDA for Biofriend Biomask Surgical Facemask, Models Universal Bf-200-2001 And Premium Bf-200-3013.
| Device ID | K101128 |
| 510k Number | K101128 |
| Device Name: | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 |
| Classification | Surgical Mask With Antimicrobial/antiviral Agent |
| Applicant | FILLIGENT LIMITED 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Ian Gordon |
| Correspondent | Ian Gordon FILLIGENT LIMITED 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | OUK |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2011-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00708820228818 | K101128 | 000 |
| 00840039200213 | K101128 | 000 |
| 00840039200527 | K101128 | 000 |
| 00840039200558 | K101128 | 000 |
| 00840039200565 | K101128 | 000 |