K143117 is an FDA 510(k) clearance for the Wire Sterilization Package with Indicators. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 29, 2015, 364 days after receiving the submission on October 30, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K143117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2014 |
| Decision Date | October 29, 2015 |
| Days to Decision | 364 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |