The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Unit, Phacofragmentation.
| Device ID | K103023 |
| 510k Number | K103023 |
| Device Name: | UNIT, PHACOFRAGMENTATION |
| Classification | Unit, Phacofragmentation |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Evelyn De La Vega |
| Correspondent | Evelyn De La Vega ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-06-01 |
| Summary: | summary |