R2GATE
System, Image Processing, Radiological
MegaGen Implant Co., Ltd.
The following data is part of a premarket notification filed by Megagen Implant Co., Ltd. with the FDA for R2gate.
Pre-market Notification Details
| Device ID | K190096 |
| 510k Number | K190096 |
| Device Name: | R2GATE |
| Classification | System, Image Processing, Radiological |
| Applicant | MegaGen Implant Co., Ltd. 41940, 10F, 12 Gong Pyeong Ro, Jung Gu Daegu, KR 41940 |
| Contact | Hyejin Jung |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-06-26 |
Trademark Results [R2GATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 R2GATE 79312171 not registered Live/Pending |
MEGAGEN IMPLANT CO., LTD. 2021-02-04 |
 R2GATE 79309186 not registered Live/Pending |
MEGAGEN IMPLANT CO., LTD. 2021-02-24 |
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