The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Compact Intuitiv; System, Wireless Remote Control, Four-button Foot Pedal, Single-use Fluidics Pack.
| Device ID | K133115 |
| 510k Number | K133115 |
| Device Name: | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Rosanne Yetemian |
| Correspondent | Rosanne Yetemian 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 | 2013-09-30 |
| Decision Date | 2014-02-27 |
| Summary: | summary |