The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Site Anterior Capsulotomer.
| Device ID | K843039 |
| 510k Number | K843039 |
| Device Name: | SITE ANTERIOR CAPSULOTOMER |
| Classification | Cannula, Ophthalmic |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Ticknor |
| Correspondent | Ticknor CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-02 |
| Decision Date | 1984-11-21 |