The following data is part of a premarket notification filed by Young Dental Manufacturing Co. 1, Llc with the FDA for Defend Ear-loop Face Masks.
| Device ID | K201127 |
| 510k Number | K201127 |
| Device Name: | DEFEND Ear-loop Face Masks |
| Classification | Mask, Surgical |
| Applicant | Young Dental Manufacturing Co. 1, LLC 13705 Shoreline Court East Earth City, MO 63045 |
| Contact | Jose Espino |
| Correspondent | Jose Espino Young Dental Manufacturing Co. 13705 Shoreline Ct. E. Earth City, MO 63045 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-28 |
| Decision Date | 2021-04-14 |