The following data is part of a premarket notification filed by Micron Corporation with the FDA for Y-mic.
| Device ID | K161639 |
| 510k Number | K161639 |
| Device Name: | Y-MIC |
| 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 | 2016-06-14 |
| Decision Date | 2016-12-22 |