The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Iolab Reusable Peristatic Cassette/ophthalmic Use.
| Device ID | K921607 |
| 510k Number | K921607 |
| Device Name: | IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE |
| Classification | Unit, Phacofragmentation |
| Applicant | CHIRON VISION CORP. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | James K Mccracken |
| Correspondent | James K Mccracken CHIRON VISION CORP. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1992-06-30 |