The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Phakosystems Model Ces 4100.
| Device ID | K851674 |
| 510k Number | K851674 |
| Device Name: | PHAKOSYSTEMS MODEL CES 4100 |
| Classification | Unit, Phacofragmentation |
| Applicant | PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada, CA M3j 2t9 |
| Contact | Keith L Carter |
| Correspondent | Keith L Carter PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada, CA M3j 2t9 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-08-05 |