VIVA Combo RF System

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 Viva Combo Rf System.

Pre-market Notification Details

Device IDK183538
510k NumberK183538
Device Name:VIVA Combo RF System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si,  KR 10355
ContactJun-young Jung
CorrespondentJun-young Jung
STARmed Co., Ltd. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu Goyang-si,  KR 10355
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-19
Decision Date2019-01-17
Summary:summary

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