The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Iolab/site Disposable Diaphragm Cassette.
| Device ID | K944994 |
| 510k Number | K944994 |
| Device Name: | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE |
| Classification | Unit, Phacofragmentation |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford 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 | 1994-10-12 |
| Decision Date | 1995-03-14 |