ArtiSential Laparoscopic Instrument-Electrodes

Electrosurgical, Cutting & Coagulation & Accessories

LivsMed Inc.

The following data is part of a premarket notification filed by Livsmed Inc. with the FDA for Artisential Laparoscopic Instrument-electrodes.

Pre-market Notification Details

Device IDK200501
510k NumberK200501
Device Name:ArtiSential Laparoscopic Instrument-Electrodes
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si,  KR 13516
ContactDong Wook Lee
CorrespondentDong Wook Lee
LivsMed Inc. #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si,  KR 13516
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-05-11

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