Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K190051 |
Device Name |
TD Clip |
Applicant |
Zephyr Sleep Technologies, Inc. |
102, 701 64 Ave SE |
Calgary,
CA
T2H 2C3
|
|
Applicant Contact |
Sabina Bruehlmann |
Correspondent |
Zephyr Sleep Technologies, Inc. |
102, 701 64 Ave SE |
Calgary,
CA
T2H 2C3
|
|
Correspondent Contact |
Sabina Bruehlmann |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 01/11/2019 |
Decision Date | 06/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|