The following data is part of a premarket notification filed by Midwest Orthodontic Mfg. with the FDA for Fluor-i-chains(tm) And Fluor-i-ties(tm).
| Device ID | K900824 |
| 510k Number | K900824 |
| Device Name: | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | MIDWEST ORTHODONTIC MFG. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
| Contact | An-shih Cheng |
| Correspondent | An-shih Cheng MIDWEST ORTHODONTIC MFG. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-05-22 |