BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
FDA 510(k) clearance K101128 · decided 2011-05-26
Clearance details
- K-number
- K101128
- Device name
- BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
- Applicant
- Filligent Limited
- Decision
- Substantially Equivalent
- Date received
- 2010-04-22
- Decision date
- 2011-05-26
- Days to decision
- 399 days
- Clearance type
- Traditional
- Product code
- OUK
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Filligent Limited
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProGear® Surgical Mask with Oxafence®, Model AV82030 (K231741) | Prestige Ameritech | 2024-09-05 |
| Innonix Antiviral Child's Face Mask (K192105) | Innonix Technologies Limited | 2019-11-29 |
| Cufitec Surgical Mask (K182766) | Nbc Meshtec, Inc. | 2019-01-03 |
Recalls involving this device
No recalls on record reference this clearance.