The following data is part of a premarket notification filed by Makrite Industries, Inc. with the FDA for Makrite Type N95 Respirator And Surgical Mask Model 910-n95.
| Device ID | K020474 |
| 510k Number | K020474 |
| Device Name: | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 |
| Classification | Respirator, Surgical |
| Applicant | MAKRITE INDUSTRIES, INC. 24 TOWER ST. Webster, MA 01570 |
| Contact | Joseph Z Zdrok |
| Correspondent | Joseph Z Zdrok MAKRITE INDUSTRIES, INC. 24 TOWER ST. Webster, MA 01570 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-07-23 |
| Summary: | summary |