The following data is part of a premarket notification filed by Nexera Medical, Inc with the FDA for Spectrashield 9500 Surgical Mask.
| Device ID | K090414 |
| 510k Number | K090414 |
| Device Name: | SPECTRASHIELD 9500 SURGICAL MASK |
| Classification | N95 Respirator With Antimicrobial/antiviral Agent |
| Applicant | NEXERA MEDICAL, INC 1556 EAST COMMERCIAL BLVD. Oakland Park, FL 33334 -5752 |
| Contact | Paul Sallarulo |
| Correspondent | Paul Sallarulo NEXERA MEDICAL, INC 1556 EAST COMMERCIAL BLVD. Oakland Park, FL 33334 -5752 |
| Product Code | ONT |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-18 |
| Decision Date | 2011-02-24 |
| Summary: | summary |