Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K111172 |
Device Name |
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES |
Applicant |
DAAVLIN DISTRIBUTING CO. |
205 WEST BEMENT ST. |
BRYAN,
OH
43506
|
|
Applicant Contact |
MICHELE THIEL |
Correspondent |
DAAVLIN DISTRIBUTING CO. |
205 WEST BEMENT ST. |
BRYAN,
OH
43506
|
|
Correspondent Contact |
MICHELE THIEL |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 04/26/2011 |
Decision Date | 08/29/2011 |
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
|
Recalls |
CDRH Recalls
|