The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Slit Lamp.
| Device ID | K073190 |
| 510k Number | K073190 |
| Device Name: | SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | HUVITZ CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019600114 | K073190 | 000 |
| 08800019600107 | K073190 | 000 |
| 08800019600046 | K073190 | 000 |
| 08800019600008 | K073190 | 000 |