Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K210881 |
Device Name |
M Series Phototherapy Equipment |
Applicant |
Daavlin Distributing Co. |
205 W. Bement Street |
Bryan,
OH
43506
|
|
Applicant Contact |
Michele Thiel |
Correspondent |
Daavlin Distributing Co. |
205 W. Bement Street |
Bryan,
OH
43506
|
|
Correspondent Contact |
Michele Thiel |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 03/25/2021 |
Decision Date | 06/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|