The following data is part of a premarket notification filed by Hai Laboratories, Inc. with the FDA for Clinical Specular Microscope, Model Hai Cl-1000xyz.
| Device ID | K994340 |
| 510k Number | K994340 |
| Device Name: | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HAI LABORATORIES, INC. 30 NORTHPOINT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto HAI LABORATORIES, INC. 30 NORTHPOINT RD. Sound Beach, NY 11789 -1734 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852194002014 | K994340 | 000 |