The following data is part of a premarket notification filed by Lonestar Meadows Llc with the FDA for Welltrust Wt-iii Mask With Flat Earloop.
| Device ID | K211751 |
| 510k Number | K211751 |
| Device Name: | WELLTRUST WT-III Mask With Flat Earloop |
| Classification | Mask, Surgical |
| Applicant | Lonestar Meadows LLC 8585 Commerce Park Dr., Suite 500 Houston, TX 77036 |
| Contact | Karthik Sundaram |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 22 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-09-17 |