The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Epsilon Ultrasonic Tip.
| Device ID | K831836 |
| 510k Number | K831836 |
| Device Name: | EPSILON ULTRASONIC TIP |
| 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 | 1983-06-07 |
| Decision Date | 1983-06-30 |