The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Sports Pack Elastics.
| Device ID | K900578 |
| 510k Number | K900578 |
| Device Name: | SPORTS PACK ELASTICS |
| 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 | 1990-02-07 |
| Decision Date | 1990-04-10 |