The following data is part of a premarket notification filed by Suzhou 66 Vision-tech Co., Ltd with the FDA for Vision-tech Yz Slit Lamp, Model 66.
| Device ID | K033190 |
| 510k Number | K033190 |
| Device Name: | VISION-TECH YZ SLIT LAMP, MODEL 66 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | SUZHOU 66 VISION-TECH CO., LTD 6833 SAINT LAWRENCE STREET Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo SUZHOU 66 VISION-TECH CO., LTD 6833 SAINT LAWRENCE STREET Plano, TX 75024 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2003-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945033901839 | K033190 | 000 |
| 06945033901822 | K033190 | 000 |
| 06945033901815 | K033190 | 000 |
| 06945033901808 | K033190 | 000 |