510(k) K122702
- Device
- BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
- Applicant
- FILLIGENT LIMITED
- 510(k) number
- K122702
- Product code
- ONT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-18
- Date received
- 2012-09-04
- Regulation
- 878.4040
- Classification name
- N95 Respirator With Antimicrobial/antiviral Agent
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAI DEUSCH
- Address
- 7th Fllor, 69 Jervois St., Sheung Wan Hong Kong CN HK HK
FDA Registration Numbers#
- 3037969189
Source Documents#
Other 510(k) Records For Product Code ONT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015-12-29 |
| K120244 | SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR | Nexera Medical, Inc. | 2012-07-05 |
| K090414 | SPECTRASHIELD 9500 SURGICAL MASK | Nexera Medical, Inc. | 2011-02-24 |
| K093161 | ACTIPROTECT UF N95 RESPIRATOR | Glaxosmithkline Consumer Healthcare | 2010-05-10 |
| K081923 | ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD | Glaxosmithkline Consumer Healthcare | 2009-07-01 |
Legacy Summary#
summary
FDA Review#
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