The following data is part of a premarket notification filed by Sis Ag, Surgical Instrument Systems with the FDA for Galilei G6 Lens Professional.
| Device ID | K182659 |
| 510k Number | K182659 |
| Device Name: | Galilei G6 Lens Professional |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | SIS AG, Surgical Instrument Systems Allmendstrasse 11 Port, CH Ch-2502 |
| Contact | Frank Ziemer |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167751242 | K182659 | 000 |