The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Hansatome Microkeratome.
| Device ID | K972808 |
| 510k Number | K972808 |
| Device Name: | HANSATOME MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-10-24 |
| Summary: | summary |