The following data is part of a premarket notification filed by Allesee Orthodontic Appliances with the FDA for Red, White & Blue.
| Device ID | K040874 |
| 510k Number | K040874 |
| Device Name: | RED, WHITE & BLUE |
| Classification | Aligner, Sequential |
| Applicant | ALLESEE ORTHODONTIC APPLIANCES 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell ALLESEE ORTHODONTIC APPLIANCES 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-06-18 |
| Summary: | summary |