The following data is part of a premarket notification filed by Aearo Company with the FDA for Aearo Company Surgical N95 Respirators, Models N9508c And N9511c.
| Device ID | K072359 |
| 510k Number | K072359 |
| Device Name: | AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C |
| 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 | 2007-08-22 |
| Decision Date | 2007-11-08 |
| Summary: | summary |