The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Phacoemulsification Sistem Remote Control.
| Device ID | K974469 |
| 510k Number | K974469 |
| Device Name: | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL |
| Classification | Unit, Phacofragmentation |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Donna A Crawford |
| Correspondent | Donna A Crawford MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-02-24 |
| Summary: | summary |