The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Super-seven Stranded Nickel-titanium Archwire.
| Device ID | K934265 |
| 510k Number | K934265 |
| Device Name: | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE |
| Classification | Wire, Orthodontic |
| Applicant | FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Contact | Brian Finander |
| Correspondent | Brian Finander FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1994-01-21 |