The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Ultrasonic Scaler, Varios 560.
| Device ID | K062731 |
| 510k Number | K062731 |
| Device Name: | ULTRASONIC SCALER, VARIOS 560 |
| Classification | Scaler, Ultrasonic |
| Applicant | NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Contact | Norimasa Kaneko |
| Correspondent | Norimasa Kaneko NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2007-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264562462 | K062731 | 000 |
| 04560264560437 | K062731 | 000 |
| 04560264560338 | K062731 | 000 |
| 04560224990786 | K062731 | 000 |
| 04560224990779 | K062731 | 000 |
| 04560224990762 | K062731 | 000 |
| 04560224990755 | K062731 | 000 |