The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Pax-500.
Device ID | K082350 |
510k Number | K082350 |
Device Name: | PAX-500 |
Classification | X-ray, Tomography, Computed, Dental |
Applicant | VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
Contact | Dave Kim |
Correspondent | Dave Kim VATECH CO., LTD. 256 NORTH SAM HOUSTON PKWY E. SUITE 115 Houston, TX 77060 |
Product Code | OAS |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-15 |
Decision Date | 2008-10-10 |
Summary: | summary |