The following data is part of a premarket notification filed by Dasoft Partners with the FDA for Advanced Dental Applicance.
Device ID | K172991 |
510k Number | K172991 |
Device Name: | Advanced Dental Applicance |
Classification | Device, Anti-snoring |
Applicant | DaSoft Partners 4079 Governer Drive #111 San Diego, CA 92122 |
Contact | Dante Togliatti |
Correspondent | Alyssa Schwartz ASchwartz Consulting 1225 Hall Road West Chester, PA 19380 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-27 |
Decision Date | 2018-07-10 |
Summary: | summary |