Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K150912 |
Device Name |
Houva-NET Control System |
Applicant |
National Biological Corporation |
23700 Mercantile Road |
Beachwood,
OH
44122
|
|
Applicant Contact |
Lynn Keller |
Correspondent |
REU Associates Inc. |
409 Woodridge Dr. |
Seneca,
SC
29672
|
|
Correspondent Contact |
Jennifer Cartledge |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 04/03/2015 |
Decision Date | 07/10/2015 |
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
|