The following data is part of a premarket notification filed by Micron Corporation with the FDA for Aw-100.
| Device ID | K171150 |
| 510k Number | K171150 |
| Device Name: | AW-100 |
| Classification | Scaler, Ultrasonic |
| Applicant | Micron Corporation 2-17-7 Ikegami Ota-ku, Tokyo, JP 146-0082 |
| Contact | Takashi Terui |
| Correspondent | Takashi Terui Micron Corporation 2-17-7 Ikegami Ota-ku, Tokyo, JP 146-0082 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2018-03-08 |
| Summary: | summary |