AGNES
Electrosurgical, Cutting & Coagulation & Accessories
Agnes Medical CO., LTD
The following data is part of a premarket notification filed by Agnes Medical Co., Ltd with the FDA for Agnes.
Pre-market Notification Details
| Device ID | K203013 |
| 510k Number | K203013 |
| Device Name: | AGNES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Agnes Medical CO., LTD (Seohyeon-Dong, 5fCocoplaza), 20, Seohyeon-Ro 210beon-Gil, Bundang-Gu, Seongnam-Si, KR 13591 |
| Contact | Chul Lee |
| Correspondent | DongHa Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2022-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800067700016 | K203013 | 000 |
| 18800067700009 | K203013 | 000 |
| 08800067700002 | K203013 | 000 |
Trademark Results [AGNES]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AGNES 88476473 5949738 Live/Registered |
Lindsey Adelman Studio LLC 2019-06-17 |
 AGNES 88346432 5895046 Live/Registered |
AMD Global Telemedicine, Inc. 2019-03-19 |
 AGNES 86834011 5080576 Live/Registered |
AGNES MEDICAL CO., LTD. 2015-11-30 |
 AGNES 86069496 not registered Dead/Abandoned |
Del Boca, Adrian, M.D., P.A. 2013-09-19 |
 AGNES 85957733 4509648 Live/Registered |
AMD Global Telemedicine 2013-06-12 |
 AGNES 77833633 not registered Dead/Abandoned |
Del Boca, Adrian, M.D., P.A. 2009-09-23 |
 AGNES 73454430 1301909 Dead/Cancelled |
CBS Inc. 1983-11-25 |
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