The following data is part of a premarket notification filed by Aearo Company with the FDA for Pleats Plus N95 Respirator, Models 1054 And 1054s.
| Device ID | K063013 |
| 510k Number | K063013 |
| Device Name: | PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S |
| 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 | 2006-10-02 |
| Decision Date | 2006-12-01 |
| Summary: | summary |