The following data is part of a premarket notification filed by Biovision Ag with the FDA for Modification To Visitome 20-10 Microkeratome.
| Device ID | K042083 |
| 510k Number | K042083 |
| Device Name: | MODIFICATION TO VISITOME 20-10 MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | BIOVISION AG 27 MAUCHLY, UNIT 206 Irvine, CA 92618 |
| Contact | Dale Sadlik |
| Correspondent | Dale Sadlik BIOVISION AG 27 MAUCHLY, UNIT 206 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 | 2004-08-03 |
| Decision Date | 2004-11-16 |
| Summary: | summary |