Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K132643 |
Device Name |
UV PHOTOTHERAPY |
Applicant |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. |
P.O. BOX 120-119 |
SHANGHAI,
CN
200120
|
|
Applicant Contact |
Diana Hong |
Correspondent |
XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. |
P.O. BOX 120-119 |
SHANGHAI,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 08/26/2013 |
Decision Date | 01/30/2014 |
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
|
|
|