The following data is part of a premarket notification filed by Prestige Ameritech with the FDA for Prestige Ameritech Pediatric/child’s Face Mask.
| Device ID | K160100 |
| 510k Number | K160100 |
| Device Name: | Prestige Ameritech Pediatric/Child’s Face Mask |
| Classification | Pediatric/child Facemask |
| Applicant | Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills, TX 76180 |
| Contact | Rodney Gregory |
| Correspondent | Rodney Gregory Prestige Ameritech 7201 Iron Horse Blvd. North Richland Hills, TX 76180 |
| Product Code | OXZ |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-10-07 |
| Summary: | summary |