The following data is part of a premarket notification filed by Aearo Company with the FDA for N95 Respirator, Models N9504c, N9504cs And N9514c.
| Device ID | K070168 |
| 510k Number | K070168 |
| Device Name: | N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C |
| Classification | Respirator, Surgical |
| Applicant | AEARO COMPANY 90 MECHANIC ST. Southbridge, MA 01550 |
| Contact | Ann L Phillips |
| Correspondent | Ann L Phillips AEARO COMPANY 90 MECHANIC ST. Southbridge, MA 01550 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-18 |
| Decision Date | 2007-04-18 |
| Summary: | summary |