The following data is part of a premarket notification filed by Prestige Ameritech with the FDA for Prestige Ameritech Face Mask.
| Device ID | K061716 |
| 510k Number | K061716 |
| Device Name: | PRESTIGE AMERITECH FACE MASK |
| Classification | Mask, Surgical |
| Applicant | Prestige Ameritech 7425 AIRPORT FWY. Ft. Worth, TX 76118 |
| Contact | Dan Reese |
| Correspondent | Dan Reese Prestige Ameritech 7425 AIRPORT FWY. Ft. Worth, TX 76118 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-19 |
| Decision Date | 2006-08-14 |
| Summary: | summary |