ACUTRON
Electrosurgical, Cutting & Coagulation & Accessories
ILOODA Co., Ltd
The following data is part of a premarket notification filed by Ilooda Co., Ltd with the FDA for Acutron.
Pre-market Notification Details
| Device ID | K211000 |
| 510k Number | K211000 |
| Device Name: | ACUTRON |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ILOODA Co., Ltd 120, Jangan-ro 458 Beon-gil, Jangan-Gu Suwon-si, KR 16200 |
| Contact | Yun-Jung Ha |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Ste 610 Houston, TX 77054 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-02 |
| Decision Date | 2022-06-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800023201444 | K211000 | 000 |
Trademark Results [ACUTRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUTRON 90352943 not registered Live/Pending |
ILOODA Co., Ltd. 2020-12-02 |
 ACUTRON 85205580 4228553 Dead/Cancelled |
Starwynn, Darren 2010-12-24 |
 ACUTRON 73731494 1574612 Dead/Expired |
DAVIS, PAUL 1988-05-31 |
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