| Device Classification Name |
Device, Jaw Repositioning
|
| 510(k) Number |
K032410 |
| Device Name |
SNORENTI |
| Applicant |
| James P Boyd |
| 710 Midori Ct. |
|
Solana Beach,
CA
92075
|
|
| Applicant Contact |
JAMES P BOYD |
| Correspondent |
| James P Boyd |
| 710 Midori Ct. |
|
Solana Beach,
CA
92075
|
|
| Correspondent Contact |
JAMES P BOYD |
| Regulation Number | 872.5570 |
| Classification Product Code |
|
| Date Received | 08/04/2003 |
| Decision Date | 02/28/2005 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|