The following data is part of a premarket notification filed by American Orthodontics with the FDA for Wire Sterilization Package With Indicators.
| Device ID | K143117 |
| 510k Number | K143117 |
| Device Name: | Wire Sterilization Package With Indicators |
| Classification | Wrap, Sterilization |
| Applicant | AMERICAN ORTHODONTICS 3524 WASHINGTON AVENUE Sheboygan, WI 53081 |
| Contact | Trang Adams |
| Correspondent | Trang Adams AMERICAN ORTHODONTICS 3524 WASHINGTON AVENUE Sheboygan, WI 53081 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-30 |
| Decision Date | 2015-10-29 |
| Summary: | summary |