The following data is part of a premarket notification filed by Sis Ltd. Surgical Instrument Systems with the FDA for Amadeus Ii Epikeratome.
| Device ID | K043150 |
| 510k Number | K043150 |
| Device Name: | AMADEUS II EPIKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-01-31 |
| Summary: | summary |