The following data is part of a premarket notification filed by Customfab, Inc. with the FDA for Surgical Mask.
| Device ID | K203012 |
| 510k Number | K203012 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Customfab, INC. 7345 Orangewood Ave Garden Grove, CA 92841 |
| Contact | Erentia Gillmer |
| Correspondent | Laura Nygard Lean RAQA, LLCX 12602 N Summer Wind Drive Marana, AZ 85658 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-04-11 |