The following data is part of a premarket notification filed by Zulaf, Inc. with the FDA for Solo Ties.
| Device ID | K930452 |
| 510k Number | K930452 |
| Device Name: | SOLO TIES |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | ZULAF, INC. P.O. BOX 6661 Lubbuck, TX 79493 |
| Contact | Rutledge Reynolds |
| Correspondent | Rutledge Reynolds ZULAF, INC. P.O. BOX 6661 Lubbuck, TX 79493 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-27 |
| Decision Date | 1993-07-08 |