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 | K120244 |
| 510k Number | K120244 |
| Device Name: | SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR |
| Classification | N95 Respirator With Antimicrobial/antiviral Agent |
| Applicant | NEXERA MEDICAL INC 3343 W Commercial Blvd Ste 103 Fort Lauderdale, FL 33309 |
| Contact | Paul Sallarulo |
| Correspondent | Paul Sallarulo NEXERA MEDICAL INC 3343 W Commercial Blvd Ste 103 Fort 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 | 2012-01-27 |
| Decision Date | 2012-07-05 |
| Summary: | summary |