The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Hansatome Excellus Microkeratome.
| Device ID | K021640 |
| 510k Number | K021640 |
| Device Name: | HANSATOME EXCELLUS MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-06-19 |
| Summary: | summary |