K891327 is an FDA 510(k) clearance for the NICKLE-TITANIUM ORTHODONTIC WIRE. This device is classified as a Detector, Air Bubble (Class II - Special Controls, product code FJF).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on May 10, 1989, 61 days after receiving the submission on March 10, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K891327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1989 |
| Decision Date | May 10, 1989 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJF — Detector, Air Bubble |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |