The following data is part of a premarket notification filed by Suzhou Kangjie Medical Inc with the FDA for Portable Slit Lamp Microscope.
| Device ID | K162778 |
| 510k Number | K162778 |
| Device Name: | Portable Slit Lamp Microscope |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | SUZHOU KANGJIE MEDICAL INC No. 129, Weixin Rd., Weiting Town Suzhou, CN 215000 |
| Contact | Hong Zhu |
| Correspondent | Di Wu DIWU Regulatory 3440 Indian Queen Lane, Rear Philadelphia, PA 19129 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-07-21 |
| Summary: | summary |