The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Ultrasonic Tips.
| Device ID | K812126 |
| 510k Number | K812126 |
| Device Name: | ULTRASONIC TIPS |
| Classification | Unit, Phacofragmentation |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-27 |
| Decision Date | 1981-09-18 |