The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Hansatome Microkeratome.
| Device ID | K010260 |
| 510k Number | K010260 |
| Device Name: | HANSATOME MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | BAUSCH & LOMB, INC. 9342 JERONIMO RD. Irvine, CA 92618 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky BAUSCH & LOMB, INC. 9342 JERONIMO RD. Irvine, CA 92618 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-04-27 |