The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Dememask.
| Device ID | K201479 |
| 510k Number | K201479 |
| Device Name: | DemeMASK |
| Classification | Mask, Surgical |
| Applicant | DemeTECH Corporation 14175 NW 60th Avenue Miami Lakes, FL 33014 |
| Contact | Tracy Chadwrick |
| Correspondent | Tracy Chadwrick DemeTECH Corporation 14175 NW 60th Avenue Miami Lakes, FL 33014 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-04 |
| Decision Date | 2020-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883940405148 | K201479 | 000 |