The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Nitinol Arch Wire.
| Device ID | K863742 |
| 510k Number | K863742 |
| Device Name: | FLEXMEDICS NITINOL ARCH WIRE |
| Classification | Wire, Orthodontic |
| Applicant | FLEXMEDICS SECTION 12 1313 FIFTH STREET, S.E. Minneapolis, MN 55414 |
| Contact | Sievert, Jr. |
| Correspondent | Sievert, Jr. FLEXMEDICS SECTION 12 1313 FIFTH STREET, S.E. Minneapolis, MN 55414 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-11-24 |