SpectraShield 9500 Surgical N95 Respirator
FDA 510(k) clearance K150729 · decided 2015-12-29
Clearance details
- K-number
- K150729
- Device name
- SpectraShield 9500 Surgical N95 Respirator
- Applicant
- Nexera Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-20
- Decision date
- 2015-12-29
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- ONT
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ft.Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR (K122702) | Filligent Limited | 2013-03-18 |
| SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (K120244) | Nexera Medical, Inc. | 2012-07-05 |
| SPECTRASHIELD 9500 SURGICAL MASK (K090414) | Nexera Medical, Inc. | 2011-02-24 |
| ACTIPROTECT UF N95 RESPIRATOR (K093161) | Glaxosmithkline Consumer Healthcare | 2010-05-10 |
| ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD (K081923) | Glaxosmithkline Consumer Healthcare | 2009-07-01 |
Recalls involving this device
No recalls on record reference this clearance.