The following data is part of a premarket notification filed by Maf Clothing Pvt Ltd Unit-3 with the FDA for Maf Guard.
| Device ID | K211487 |
| 510k Number | K211487 |
| Device Name: | MAF Guard |
| Classification | Mask, Surgical |
| Applicant | MAF Clothing Pvt Ltd Unit-3 Sy. No59/3, 59/4, Rajathadripura, Near K B Cross Karnataka, IN 572114 |
| Contact | Kirit Jagani |
| Correspondent | Thomas C. Knott Benjamin L. England And Associates, LLC 810 Landmark Dr, Suite 126 Glen Burnie, MD 21061 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-13 |
| Decision Date | 2021-12-08 |