The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Dental Computed Tomography X-ray System.
Device ID | K102259 |
510k Number | K102259 |
Device Name: | DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | VATECH CO., LTD. 333 MEADOWLANDS PARKWAY, #303 Secaucus, NJ 07094 |
Contact | Dave Kim |
Correspondent | Dave Kim VATECH CO., LTD. 333 MEADOWLANDS PARKWAY, #303 Secaucus, NJ 07094 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-10 |
Decision Date | 2011-02-18 |
Summary: | summary |