Smoklean

Apparatus, Exhaust, Surgical

Sejong Medical Co., Ltd.

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

Pre-market Notification Details

Device IDK173108
510k NumberK173108
Device Name:Smoklean
ClassificationApparatus, Exhaust, Surgical
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 CodeFYD  
CFR Regulation Number878.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-05-18
Summary:summary

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