The following data is part of a premarket notification filed by Glaxosmithkline Consumer Healthcare with the FDA for Actiprotect Uf N95 Respirator.
| Device ID | K093161 |
| 510k Number | K093161 |
| Device Name: | ACTIPROTECT UF N95 RESPIRATOR |
| Classification | N95 Respirator With Antimicrobial/antiviral Agent |
| Applicant | GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Contact | Zinatara A Manji |
| Correspondent | Zinatara A Manji GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Product Code | ONT |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-06 |
| Decision Date | 2010-05-10 |
| Summary: | summary |