The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Blugoo Hd.
| Device ID | K071192 |
| 510k Number | K071192 |
| Device Name: | BLUGOO HD |
| Classification | Material, Impression |
| Applicant | LANCER ORTHODONTICS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland LANCER ORTHODONTICS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-06-22 |
| Summary: | summary |