The following data is part of a premarket notification filed by Entreprise Premont Inc. with the FDA for Humask Pro Vision, Humask Pro Vision 3000.
| Device ID | K222551 |
| 510k Number | K222551 |
| Device Name: | Humask Pro Vision, Humask Pro Vision 3000 |
| Classification | Mask, Surgical |
| Applicant | Entreprise Premont Inc. 731 Boul. Saint-Laurent Est Louiseville, CA J5V 1J1 |
| Contact | Charlie Marchand |
| Correspondent | Charlie Marchand Enterprise Premont Inc. 731 Boulevard Saint-Laurent Est Louiseville, CA J5V 1J1 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864060888 | K222551 | 000 |