The following data is part of a premarket notification filed by Abbott Medical Optics Inc. with the FDA for Compact Intuitiv Multiple-use Pack.
| Device ID | K151783 |
| 510k Number | K151783 |
| Device Name: | COMPACT INTUITIV Multiple-Use Pack |
| Classification | Unit, Phacofragmentation |
| Applicant | Abbott Medical Optics Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 |
| Contact | Priya Viswanathan |
| Correspondent | Priya Viswanathan Abbott Medical Optics Inc. 1700 East 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 | 2015-07-01 |
| Decision Date | 2015-09-02 |
| Summary: | summary |