The following data is part of a premarket notification filed by Agnes Medical Co., Ltd with the FDA for Agnes.
Device ID | K192728 |
510k Number | K192728 |
Device Name: | Agnes |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Agnes Medical Co., Ltd (Seohyeon-Dong, 5f Cocoplaza), 20, Seohyeon-Ro 210beon-Gil, Bundang-Gu Seongnam-si, KR 13591 |
Contact | Seunghwan Seo |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-27 |
Decision Date | 2019-10-24 |
Summary: | summary |
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 |