The following data is part of a premarket notification filed by Gri-alleset, Inc with the FDA for Comfort Guard Mask, Level 1, Comfort Guard Mask, Level 3.
| Device ID | K210860 |
| 510k Number | K210860 |
| Device Name: | Comfort Guard Mask, Level 1, Comfort Guard Mask, Level 3 |
| Classification | Mask, Surgical |
| Applicant | GRI-Alleset, Inc 4142 Industry Way Flowery Branch, GA 30542 |
| Contact | Martin Paugh |
| Correspondent | Tommy Zhou GRI-Alleset, Inc 4142 Industry Way Flowery Branch, GA 30542 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2022-04-07 |