The following data is part of a premarket notification filed by Norwood Abbey , Ltd. with the FDA for Centurion Ses Epikeratome.
| Device ID | K042810 |
| 510k Number | K042810 |
| Device Name: | CENTURION SES EPIKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | NORWOOD ABBEY , LTD. 63 WELLS RD. Chelsea Hgts., Victoria, AU 3196 |
| Contact | Paul Clark |
| Correspondent | Paul Clark NORWOOD ABBEY , LTD. 63 WELLS RD. Chelsea Hgts., Victoria, AU 3196 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-10-28 |
| Summary: | summary |