Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K203477 |
Device Name |
Classic |
Applicant |
Orthoapnea S.L. |
C / Flauta Magica 22 |
Malaga,
ES
29006
|
|
Applicant Contact |
Jose Repolles Llecha |
Correspondent |
Orthoapnea S.L. |
C / Flauta Magica 22 |
Malaga,
ES
29006
|
|
Correspondent Contact |
Jose Repolles Llecha |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 11/27/2020 |
Decision Date | 02/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|