FDA Product Code
FDA Product Code OUK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | 2024-09-05 | Traditional | PDF ↗ |
| K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | 2019-11-29 | Traditional | PDF ↗ |
| K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | 2019-01-03 | Traditional | PDF ↗ |
| K101128 | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 | Filligent Limited | 2011-05-26 | Traditional | PDF ↗ |
Product code OUK · Class II · General, Plastic Surgery. Data: openFDA.