The following data is part of a premarket notification filed by Glaxosmithkline Consumer Healthcare with the FDA for Actiprotect Uc N95 Respirator.
| Device ID | K093189 |
| 510k Number | K093189 |
| Device Name: | ACTIPROTECT UC N95 RESPIRATOR |
| Classification | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies |
| Applicant | GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Contact | Zinatara Manji |
| Correspondent | Zinatara Manji GLAXOSMITHKLINE CONSUMER HEALTHCARE 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Product Code | NZJ |
| CFR Regulation Number | 880.6260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-07-02 |
| Summary: | summary |