The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Mendez U/s Cystotome.
| Device ID | K843386 |
| 510k Number | K843386 |
| Device Name: | MENDEZ U/S CYSTOTOME |
| Classification | Unit, Phacofragmentation |
| Applicant | COOPERVISION, INC. P.O. BOX 19587 Irvine , CA 92713 - |
| Contact | Douglas G Allen |
| Correspondent | Douglas G Allen COOPERVISION, INC. P.O. BOX 19587 Irvine , CA 92713 - |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-11-27 |