The following data is part of a premarket notification filed by Highland Metals with the FDA for Reverse Curve Niti Arch Wire Repacker Relabeter.
| Device ID | K933378 |
| 510k Number | K933378 |
| Device Name: | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER |
| Classification | Wire, Orthodontic |
| Applicant | HIGHLAND METALS P.O. BOX 23216 San Jose, CA 95153 |
| Contact | Kenneth Highland |
| Correspondent | Kenneth Highland HIGHLAND METALS P.O. BOX 23216 San Jose, CA 95153 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1993-11-12 |