The following data is part of a premarket notification filed by Microdental, Inc. with the FDA for Micr02 Osa Device.
| Device ID | K133683 |
| 510k Number | K133683 |
| Device Name: | MICR02 OSA DEVICE |
| Classification | Device, Anti-snoring |
| Applicant | MICRODENTAL, INC. 5601 ARNOLD RD. Dublin, CA 94568 |
| Contact | Laura Sheppard |
| Correspondent | Laura Sheppard MICRODENTAL, INC. 5601 ARNOLD RD. Dublin, CA 94568 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-02 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863039000423 | K133683 | 000 |
| 00863039000416 | K133683 | 000 |