Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K170825 |
Device Name |
SnoreRx |
Applicant |
Apnea Sciences Corporation |
27121 Aliso Creek Road, Bldg 140 |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
James Fallon |
Correspondent |
James Smith Ph.D. |
24982 Barclay Lane |
Laguna Niguel,
CA
92677
|
|
Correspondent Contact |
James Smith |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 03/20/2017 |
Decision Date | 08/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|