DemeMASK
510(k) K201479
DemeMASK is a Class II device made by Demetech Corporation, cleared under FDA 510(k) K201479 on 24 Jul 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201479 | Date24 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K201479
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FXX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201479
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Surgical Mask 559250P | 559250P / 559250P | 00883940405148 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code FXX (Mask, Surgical).
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- ENDICOTT & BEAMAN SUPRA-TEC FACE MASK by Endicott & Beaman, Inc.
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