The following data is part of a premarket notification filed by Allesee Orthodontic Appliances with the FDA for Fs Aligner.
| Device ID | K093821 |
| 510k Number | K093821 |
| Device Name: | FS ALIGNER |
| Classification | Aligner, Sequential |
| Applicant | ALLESEE ORTHODONTIC APPLIANCES 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman 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 | 2009-12-14 |
| Decision Date | 2010-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889989061987 | K093821 | 000 |