The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Dental Ultrasonic Scaler/endosonic.
| Device ID | K840141 |
| 510k Number | K840141 |
| Device Name: | DENTAL ULTRASONIC SCALER/ENDOSONIC |
| Classification | Scaler, Ultrasonic |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-05 |
| Decision Date | 1984-03-16 |