The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Mustang, C.a.t..
Device ID | K901957 |
510k Number | K901957 |
Device Name: | MUSTANG, C.A.T. |
Classification | Bracket, Metal, Orthodontic |
Applicant | LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008 |
Contact | Mike Ekinaka |
Correspondent | Mike Ekinaka LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-01 |
Decision Date | 1990-07-30 |