The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Green16/green18 (model: Pht-65lhs).
| Device ID | K170066 |
| 510k Number | K170066 |
| Device Name: | Green16/Green18 (Model: PHT-65LHS) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | VATECH CO., LTD. 13, Samsung 1-ro 2-gil Hwaseong-si, KR 445-170 |
| 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 | 2017-01-09 |
| Decision Date | 2017-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016400601 | K170066 | 000 |
| 08800016400595 | K170066 | 000 |