| Device Classification Name |
Device, Jaw Repositioning
|
| 510(k) Number |
K960673 |
| FOIA Releasable 510(k) |
K960673
|
| Device Name |
OSAP |
| Applicant |
| Snorefree, Inc. |
| 191 Connetquot Ave. |
|
East Islip,
NY
11730 -1416
|
|
| Applicant Contact |
GERALD J SCHNAL |
| Correspondent |
| Snorefree, Inc. |
| 191 Connetquot Ave. |
|
East Islip,
NY
11730 -1416
|
|
| Correspondent Contact |
GERALD J SCHNAL |
| Regulation Number | 872.5570 |
| Classification Product Code |
|
| Date Received | 02/20/1996 |
| Decision Date | 05/09/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|