The following data is part of a premarket notification filed by Tucker & Associates with the FDA for Surgical Face Mask - Colors: White, Yellow, Pink, Blue, And Green.
| Device ID | K022256 |
| 510k Number | K022256 |
| Device Name: | SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN |
| Classification | Mask, Surgical |
| Applicant | TUCKER & ASSOCIATES 198 AVE. DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Contact | Janna Tucker |
| Correspondent | Janna Tucker TUCKER & ASSOCIATES 198 AVE. DE LA D'EMERALD Sparks, NV 89434 -9550 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2004-04-26 |
| Summary: | summary |