Mygen M-3004 RF Generator M-3004

Electrosurgical, Cutting & Coagulation & Accessories

RF Medical Co., Ltd

The following data is part of a premarket notification filed by Rf Medical Co., Ltd with the FDA for Mygen M-3004 Rf Generator M-3004.

Pre-market Notification Details

Device IDK221277
510k NumberK221277
Device Name:Mygen M-3004 RF Generator M-3004
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant RF Medical Co., Ltd #502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu, Seoul,  KR 08511
ContactKwang S Choi
CorrespondentDave Kim
Mtech Group 7505 Fannin St, Suite 610 Houston,  TX  77054
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-03
Decision Date2022-09-02

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