Star RF Electrode, VIVA RF Electrode

Electrosurgical, Cutting & Coagulation & Accessories

STARmed Co., Ltd.

The following data is part of a premarket notification filed by Starmed Co., Ltd. with the FDA for Star Rf Electrode, Viva Rf Electrode.

Pre-market Notification Details

Device IDK203795
510k NumberK203795
Device Name:Star RF Electrode, VIVA RF Electrode
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant STARmed Co., Ltd. B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si,  KR 10355
ContactJun-young Jung
CorrespondentJun-young Jung
STARmed Co., Ltd. B-dong, 4F&12F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si,  KR 10355
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-04-01

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