510(k) K201483
K201483 is an FDA 510(k) premarket notification submitted by Zhengzhou Huaer Electro Optics Technology Co., Ltd. for the device "Impression Material". The FDA issued a decision of Substantially Equivalent on Oct 8, 2020. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 2020
- Date Received
- Jun 4, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)