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 |