The following data is part of a premarket notification filed by Chiron Intraoptics with the FDA for Phacotron Gold Multifunction Ultrasonic Handpiece.
| Device ID | K925631 |
| 510k Number | K925631 |
| Device Name: | PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | CHIRON INTRAOPTICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson CHIRON INTRAOPTICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-07-29 |