The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Pax-i3d Green Premium (model: Pct-90lh).
Device ID | K160882 |
510k Number | K160882 |
Device Name: | PaX-i3D Green Premium (Model: PCT-90LH) |
Classification | X-ray, Tomography, Computed, Dental |
Applicant | VATECH CO., LTD 13, SAMSUNG 1-RO 2-GIL Hwaseong-si, KR 18449 |
Contact | Daniel Kim |
Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
Product Code | OAS |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-31 |
Decision Date | 2016-10-28 |
Summary: | summary |