The following data is part of a premarket notification filed by Tidi Products, Llc with the FDA for Tidi Facemask.
| Device ID | K100800 |
| 510k Number | K100800 |
| Device Name: | TIDI FACEMASK |
| Classification | Mask, Surgical |
| Applicant | TIDI PRODUCTS, LLC 570 ENTERPRISE DR. Neenah, WI 54956 |
| Contact | Dion Brandt |
| Correspondent | Dion 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 | 2010-03-22 |
| Decision Date | 2010-06-14 |
| Summary: | summary |