Electrosurgical, Cutting & Coagulation & Accessories

Sejong Medical Co., Ltd.

The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Lap-ix.

Pre-market Notification Details

Device IDK200639
510k NumberK200639
Device Name:LAP-iX
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si,  CN 10880
ContactYoojung Choi
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2021-09-29

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