The following data is part of a premarket notification filed by Livsmed Inc. with the FDA for Artisential Bipolar Fenestrated Forceps.
| Device ID | K190909 |
| 510k Number | K190909 |
| Device Name: | ArtiSential Bipolar Fenestrated Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Livsmed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, KR 13516 |
| Contact | Dong Wook Lee |
| Correspondent | Do Hyun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5 Seoul, KR 06210 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 88000427000278 | K190909 | 000 |
| 88000427000100 | K190909 | 000 |
| 08800042700027 | K190909 | 000 |
| 08800042700010 | K190909 | 000 |