The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee-fischer Ceramic Reinforced Plastic Brackets.
| Device ID | K900809 |
| 510k Number | K900809 |
| Device Name: | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Contact | Lee, Ph.d. |
| Correspondent | Lee, Ph.d. LEE PHARMACEUTICALS 1444 SANTA ANITA P.O. BOX 3836 South El Monte, CA 91733 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-06-28 |