Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K051330 |
Device Name |
UVBIOTEK MODELS 3200B AND 4000B |
Applicant |
MEDTEK LIGHTING CORPORATION |
2840 SCHERER DRIVE N. |
SAINT PETERSBURG,
FL
33716
|
|
Applicant Contact |
ROBERT T WAGNER |
Correspondent |
MEDTEK LIGHTING CORPORATION |
2840 SCHERER DRIVE N. |
SAINT PETERSBURG,
FL
33716
|
|
Correspondent Contact |
ROBERT T WAGNER |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 05/20/2005 |
Decision Date | 11/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|