Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K153749 |
Device Name |
3 Series Phototherapy Unit |
Applicant |
DAAVLIN DISTRIBUTING COMPANY |
205 WEST BEMENT STREET |
BRYAN,
OH
43506
|
|
Applicant Contact |
MICHELE THIEL |
Correspondent |
DAAVLIN DISTRIBUTING COMPANY |
205 WEST BEMENT STREET |
BRYAN,
OH
43506
|
|
Correspondent Contact |
MICHELE THIEL |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 12/29/2015 |
Decision Date | 06/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|