The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Varios 75.
| Device ID | K071447 |
| 510k Number | K071447 |
| Device Name: | VARIOS 75 |
| Classification | Scaler, Ultrasonic |
| Applicant | NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi, Tochigi-ken, JP 322-8666 |
| Contact | Tomoko Hirabayashi |
| Correspondent | Tomoko Hirabayashi 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 | 2007-05-24 |
| Decision Date | 2008-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264562431 | K071447 | 000 |
| 04560224972614 | K071447 | 000 |
| 04560224985089 | K071447 | 000 |
| 04560224985096 | K071447 | 000 |
| 04560224985126 | K071447 | 000 |
| 04560224985133 | K071447 | 000 |
| 04560224990656 | K071447 | 000 |
| 04560264504639 | K071447 | 000 |
| 04560264560314 | K071447 | 000 |
| 04560264560321 | K071447 | 000 |
| 04560264560468 | K071447 | 000 |
| 04560264560482 | K071447 | 000 |
| 04560264560499 | K071447 | 000 |
| 04560264562370 | K071447 | 000 |
| 04560264562387 | K071447 | 000 |
| 04560264562394 | K071447 | 000 |
| 04560264562400 | K071447 | 000 |
| 04560224972065 | K071447 | 000 |