K-number	K221277
Device name	Mygen M-3004 RF Generator M-3004
Applicant	RF Medical Co., Ltd.
Product code	GEI
Device class	Class II
Decision date	Sep 2, 2022
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Mygen M-3004 RF Generator M-3004

Everything you need for a 510(k) submission. Nothing you don't.