The following data is part of a premarket notification filed by Prestige Ameritech with the FDA for Surgical Earloop Face Mask With Bottom Gap Shield And Surgical Tie-on Face Mask With Bottom Gap Shield.
| Device ID | K171162 |
| 510k Number | K171162 |
| Device Name: | Surgical Earloop Face Mask With Bottom Gap Shield And Surgical Tie-On Face Mask With Bottom Gap Shield |
| Classification | Mask, Surgical |
| Applicant | Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills, TX 76180 |
| Contact | Rex Reese |
| Correspondent | Rex Reese Prestige Ameritech 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 | 2017-04-20 |
| Decision Date | 2017-08-15 |