The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Slit Lamp, Models Hs-5000, Hs-5500 And Hs-7500.
| Device ID | K093639 |
| 510k Number | K093639 |
| Device Name: | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | HUVITZ CO., LTD. 136 W. ORION SUITE 3 Tempe, AZ 85283 |
| Contact | Matew J Wess |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-24 |
| Decision Date | 2009-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019600060 | K093639 | 000 |
| 08800019600053 | K093639 | 000 |
| 08800019600015 | K093639 | 000 |
| 08800019600077 | K093639 | 000 |
| 08800019600039 | K093639 | 000 |
| 08800019600022 | K093639 | 000 |