The following data is part of a premarket notification filed by Shanghai Mediworks Precision Instruments Co. Ltd. with the FDA for Mediworks Slit Lamp.
| Device ID | K100439 |
| 510k Number | K100439 |
| Device Name: | MEDIWORKS SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. 1485 ANDREW DR SUITE G Claremont, CA 91711 |
| Contact | Lisa Zhang |
| Correspondent | Lisa Zhang SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. 1485 ANDREW DR SUITE G Claremont, CA 91711 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945087535028 | K100439 | 000 |
| 06945087590003 | K100439 | 000 |
| 06945087530023 | K100439 | 000 |
| 06945087540015 | K100439 | 000 |
| 06945087540022 | K100439 | 000 |
| 06945087530016 | K100439 | 000 |
| 06945033901846 | K100439 | 000 |
| 06945033901853 | K100439 | 000 |
| 06945033901860 | K100439 | 000 |
| 06945033901877 | K100439 | 000 |
| 06945033901884 | K100439 | 000 |
| 06945087528013 | K100439 | 000 |
| 06945087528020 | K100439 | 000 |
| 06945087535011 | K100439 | 000 |
| 06945087520000 | K100439 | 000 |