The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Infiniti Vision System With Ozil Ip.
| Device ID | K082845 |
| 510k Number | K082845 |
| Device Name: | INFINITI VISION SYSTEM WITH OZIL IP |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Michael Buenger |
| Correspondent | Michael Buenger ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2009-02-12 |
| Summary: | summary |