The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Modification To Ciba Vision Centurion Ses Spikeratome.
| Device ID | K032978 |
| 510k Number | K032978 |
| Device Name: | MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2003-10-20 |
| Summary: | summary |