The following data is part of a premarket notification filed by Flexmedics with the FDA for Flex Plastic Plastic Coated Nitinol Arch Wire.
| Device ID | K883120 |
| 510k Number | K883120 |
| Device Name: | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Contact | Jim Stice |
| Correspondent | Jim Stice 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 | 1988-07-26 |
| Decision Date | 1988-11-14 |