The following data is part of a premarket notification filed by Flexmedics with the FDA for Rectangular Nitinol Arch Wire.
| Device ID | K881163 |
| 510k Number | K881163 |
| Device Name: | RECTANGULAR NITINOL ARCH WIRE |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Contact | Sievert, Jr. |
| Correspondent | Sievert, Jr. FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-04-07 |