510(k) K161639
K161639 is an FDA 510(k) premarket notification submitted by Micron Corporation for the device "Y-MIC". The FDA issued a decision of Substantially Equivalent on Dec 22, 2016. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Micron Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2016
- Date Received
- Jun 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type
- 510(k)