The following data is part of a premarket notification filed by Dasoft Partners with the FDA for Advanced Dental Appliance.
Device ID | K203462 |
510k Number | K203462 |
Device Name: | Advanced Dental Appliance |
Classification | Device, Anti-snoring |
Applicant | DaSoft Partners 4079 Governor Drive #111 San Diego, CA 92122 |
Contact | Dante Togliatti |
Correspondent | Kimberly Lane J Blane, LLC 980 N Sinagua Heights Dr Flagstaff, AZ 86004 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-24 |
Decision Date | 2021-02-19 |