The following data is part of a premarket notification filed by Estee Exports Health Care Division with the FDA for Velguard Surgical Face Mask.
| Device ID | K210761 |
| 510k Number | K210761 |
| Device Name: | Velguard Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Estee Exports Health Care Division 8/3176 A3 & A4, Jothipuram, 2nd Street, Pandian Nagar, PN Road Tirupur, IN 641602 |
| Contact | Zachary Wilson |
| Correspondent | Amy Fowler Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata, MN 55391 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-07-16 |