The following data is part of a premarket notification filed by Family Dental Services, P.c. with the FDA for Therasom-cast.
| Device ID | K113516 |
| 510k Number | K113516 |
| Device Name: | THERASOM-CAST |
| Classification | Device, Anti-snoring |
| Applicant | FAMILY DENTAL SERVICES, P.C. 2180 SATELLITE BOULEVARD SUITE 400 Duluth, GA 30097 |
| Contact | Deanna L Baxam |
| Correspondent | Deanna L Baxam FAMILY DENTAL SERVICES, P.C. 2180 SATELLITE BOULEVARD SUITE 400 Duluth, GA 30097 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-29 |
| Decision Date | 2013-01-04 |
| Summary: | summary |