The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Iocare Irrigation & Aspiration Pack.
| Device ID | K834340 |
| 510k Number | K834340 |
| Device Name: | IOCARE IRRIGATION & ASPIRATION PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-12 |
| Decision Date | 1984-04-05 |