The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Asept Surgical Face Mask.
| Device ID | K201137 |
| 510k Number | K201137 |
| Device Name: | Asept Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | PFM Medical, Inc 1916 Palomar Oaks Way, Suite 150 Carlsbad, CA 92008 |
| Contact | Jessica Jho |
| Correspondent | Jessica Jho PFM Medical, Inc 1916 Palomar Oaks Way, Suite 150 Carlsbad, CA 92008 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-28 |
| Decision Date | 2020-08-19 |