The following data is part of a premarket notification filed by Prestige Ameritech, Ltd with the FDA for Communicator Surgical Facemask With Clear Window.
| Device ID | K152561 |
| 510k Number | K152561 |
| Device Name: | Communicator Surgical Facemask With Clear Window |
| Classification | Mask, Surgical |
| Applicant | Prestige Ameritech, Ltd 7201 Iron Horse Blvd. North Richland Hills, TX 76180 |
| Contact | Rex Reese |
| Correspondent | Rex Reese Prestige Ameritech, Ltd. 7201 Iron Horse Blvd. North Richland Hills, TX 76180 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-09 |
| Decision Date | 2016-06-03 |