The following data is part of a premarket notification filed by Phu Bao Group Company Limited with the FDA for Perfetta Moderate Medical Face Mask.
| Device ID | K222426 |
| 510k Number | K222426 |
| Device Name: | Perfetta Moderate Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Phu Bao Group Company Limited 5 Floor, CJ Building, 02Bis-4-6 Le Thanh Ton Street Ben Nghe Ward, District 1 Ho Chi Minh, VN 70000 |
| Contact | Le Pham Minh Ngoc |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-08-11 |
| Decision Date | 2022-09-02 |