The following data is part of a premarket notification filed by Aearo Co. with the FDA for Pleats Plus N95 Particulate Respirator, Models 1050 And 1050s.
| Device ID | K041855 |
| 510k Number | K041855 |
| Device Name: | PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S |
| Classification | Respirator, Surgical |
| Applicant | AEARO CO. 90 MECHANIC ST. Southbridge, MA 01550 |
| Contact | Ann Phillips |
| Correspondent | Bahram Barzideh UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-09 |
| Decision Date | 2004-11-10 |
| Summary: | summary |