The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pax-flex3d, Pht-7000.
Device ID | K121412 |
510k Number | K121412 |
Device Name: | PAX-FLEX3D, PHT-7000 |
Classification | X-ray, Tomography, Computed, Dental |
Applicant | VATECH CO., LTD. 12946 KIMBERLEY LN Houston, TX 77079 |
Contact | Dave Kim |
Correspondent | Dave Kim VATECH CO., LTD. 12946 KIMBERLEY LN Houston, TX 77079 |
Product Code | OAS |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-11 |
Decision Date | 2012-06-08 |
Summary: | summary |