The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pht-6500, Pht-60cfo.
Device ID | K130432 |
510k Number | K130432 |
Device Name: | PHT-6500, PHT-60CFO |
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 | 2013-02-21 |
Decision Date | 2013-05-31 |
Summary: | summary |