Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K162778 |
Device Name |
Portable Slit Lamp Microscope |
Applicant |
SUZHOU KANGJIE MEDICAL INC |
No. 129, Weixin Rd., Weiting Town |
Suzhou,
CN
215000
|
|
Applicant Contact |
Hong Zhu |
Correspondent |
DIWU Regulatory |
3440 Indian Queen Lane, Rear |
Philadelphia,
PA
19129
|
|
Correspondent Contact |
Di Wu |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 07/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|