FDA Product Code
FDA Product Code ONT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015-12-29 | Traditional | PDF ↗ |
| K122702 | BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR | Filligent Limited | 2013-03-18 | Traditional | PDF ↗ |
| K120244 | SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR | Nexera Medical, Inc. | 2012-07-05 | Traditional | PDF ↗ |
| K090414 | SPECTRASHIELD 9500 SURGICAL MASK | Nexera Medical, Inc. | 2011-02-24 | Traditional | PDF ↗ |
| K093161 | ACTIPROTECT UF N95 RESPIRATOR | Glaxosmithkline Consumer Healthcare | 2010-05-10 | Abbreviated | PDF ↗ |
| K081923 | ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD | Glaxosmithkline Consumer Healthcare | 2009-07-01 | Traditional | PDF ↗ |
Product code ONT · Class II · General, Plastic Surgery. Data: openFDA.