The following data is part of a premarket notification filed by Gebauer Medizintechnik Gmbh with the FDA for Epitome System.
| Device ID | K041206 |
| 510k Number | K041206 |
| Device Name: | EPITOME SYSTEM |
| Classification | Keratome, Ac-powered |
| Applicant | GEBAUER MEDIZINTECHNIK GMBH 54 FOREST STREET Lexington, MA 02421 |
| Contact | Kimberley Doney |
| Correspondent | Kimberley Doney GEBAUER MEDIZINTECHNIK GMBH 54 FOREST STREET Lexington, MA 02421 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-07 |
| Decision Date | 2004-09-15 |
| Summary: | summary |