Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K134009 |
Device Name |
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL |
Applicant |
MEDTEK LIGHTING |
2424 DEMPSTER DRIVE |
CORALVILLE,
IA
52241
|
|
Applicant Contact |
SUSAN ANTHONEY-DE WET |
Correspondent |
MEDTEK LIGHTING |
2424 DEMPSTER DRIVE |
CORALVILLE,
IA
52241
|
|
Correspondent Contact |
SUSAN ANTHONEY-DE WET |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 12/30/2013 |
Decision Date | 10/15/2014 |
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
|