LAP-iX

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 IDK173112
510k NumberK173112
Device Name:LAP-iX
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si,  KR 10880
ContactYoojung Choi
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 690 Roosevelt Irvine,  CA  92620
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-11-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.