The following data is part of a premarket notification filed by Tidi Products,llc with the FDA for Tidi Facemask.
| Device ID | K092580 |
| 510k Number | K092580 |
| Device Name: | TIDI FACEMASK |
| Classification | Mask, Surgical |
| Applicant | TIDI PRODUCTS,LLC 570 ENTERPRISE DR. Neenah, WI 54956 |
| Contact | Dion J Brandt |
| Correspondent | Dion J Brandt TIDI PRODUCTS,LLC 570 ENTERPRISE DR. Neenah, WI 54956 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-21 |
| Decision Date | 2010-02-23 |
| Summary: | summary |