Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K103540 |
Device Name |
PSORIA-LIGHT |
Applicant |
PSORIA-SHIELD INC. |
19404 PINE VALLEY DR. |
ODESSA,
FL
33556
|
|
Applicant Contact |
WAYNE GLOVER |
Correspondent |
PSORIA-SHIELD INC. |
19404 PINE VALLEY DR. |
ODESSA,
FL
33556
|
|
Correspondent Contact |
WAYNE GLOVER |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 12/02/2010 |
Decision Date | 02/10/2011 |
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
|