The following data is part of a premarket notification filed by Nexera Medical Inc. with the FDA for Spectrashield 9500 Surgical N95 Respirator.
| Device ID | K150729 |
| 510k Number | K150729 |
| Device Name: | SpectraShield 9500 Surgical N95 Respirator |
| Classification | N95 Respirator With Antimicrobial/antiviral Agent |
| Applicant | Nexera Medical Inc. 3343 West Commercial Blvd, Suite 103 Ft.lauderdale, FL 33309 |
| Contact | Paul Sallarulo |
| Correspondent | Paul Sallarulo Nexera Medical Inc. 3343 West Commercial Blvd, Suite 103 Ft.lauderdale, FL 33309 |
| Product Code | ONT |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-12-29 |