GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

Electrosurgical, Cutting & Coagulation & Accessories

Gowoonsesang Cosmetics Co., Ltd

The following data is part of a premarket notification filed by Gowoonsesang Cosmetics Co., Ltd with the FDA for Ga-b, Ga-c, Ga-e, Ga-i, Ga-s, Ga-w3a, Ga-f3a, Ga-il, Ga-sl, Ga-w3b, Ga-f1a.

Pre-market Notification Details

Device IDK171707
510k NumberK171707
Device Name:GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Gowoonsesang Cosmetics Co., Ltd (Seohyeon-dong, 4, 5F Cocoplaza) 20, Seohyeon-ro 210beon-gil, Bundang-gu Seongnam-si,  KR 13591
ContactKyeong Tai Ko
CorrespondentDongha Lee
KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil Guro-gu Seoul,  KR 08375
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-08
Decision Date2017-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18800067700139 K171707 000
18800067700030 K171707 000
18800067700047 K171707 000
18800067700054 K171707 000
18800067700061 K171707 000
18800067700078 K171707 000
18800067700085 K171707 000
18800067700092 K171707 000
18800067700108 K171707 000
18800067700115 K171707 000
18800067700122 K171707 000
18800067700023 K171707 000

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