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 ID: K221277
• 510k Number: K221277
• Device Name: Mygen M-3004 RF Generator M-3004
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: RF Medical Co., Ltd #502, 503, 506, 511, 254, Beotkkot-ro, Geumcheon-gu, Seoul, KR 08511
• Contact: Kwang S Choi
• Correspondent: Dave Kim; Mtech Group 7505 Fannin St, Suite 610 Houston, TX 77054
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-03
• Decision Date: 2022-09-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809295141328	K221277	000
08800142923067	K221277	000
08800142923050	K221277	000
08800142923043	K221277	000
08800142923036	K221277	000
08800142923029	K221277	000
08800142923012	K221277	000
08800142922435	K221277	000
08800142922428	K221277	000
08800142922411	K221277	000
08800142922404	K221277	000
08800142922398	K221277	000
08800142923074	K221277	000
08800142923081	K221277	000
08809295141311	K221277	000
08809295141304	K221277	000
08809295141298	K221277	000
08809295141281	K221277	000
08809295141274	K221277	000
08809295141236	K221277	000
08809295141229	K221277	000
08809295141212	K221277	000
08809295141205	K221277	000
08809295141199	K221277	000
08809295141151	K221277	000
08800142922374	K221277	000
08800142922367	K221277	000
08800142907012	K221277	000
08800142907005	K221277	000
08800142906909	K221277	000
08800142906893	K221277	000
08800142906886	K221277	000
08800142906572	K221277	000
08800142906565	K221277	000
08800142906558	K221277	000
08800142906541	K221277	000
08800142906534	K221277	000
08800142906459	K221277	000
08800142907029	K221277	000
08800142909917	K221277	000
08800142922282	K221277	000
08800142922275	K221277	000
08800142922268	K221277	000
08800142922251	K221277	000
08800142922244	K221277	000
08800142922220	K221277	000
08800142922213	K221277	000
08800142922077	K221277	000
08800142922022	K221277	000
08800142922015	K221277	000
08800142910029	K221277	000
08800142906442	K221277	000
08809559960962	K221277	000
08809295149423	K221277	000
08809295149089	K221277	000
08809295149072	K221277	000
08809295149065	K221277	000
08809295149058	K221277	000
08809295149041	K221277	000
08809295149034	K221277	000
08809295149027	K221277	000
08809295149010	K221277	000
08809295149003	K221277	000
08809295148990	K221277	000
08809295149430	K221277	000
08809295149447	K221277	000
08809295149591	K221277	000
08809295149584	K221277	000
08809295149577	K221277	000
08809295149560	K221277	000
08809295149553	K221277	000
08809295149522	K221277	000
08809295149515	K221277	000
08809295149508	K221277	000
08809295149492	K221277	000
08809295149485	K221277	000
08809295149454	K221277	000
08809295148983	K221277	000
08809295148976	K221277	000
08809295141830	K221277	000
08809295141823	K221277	000
08809295141816	K221277	000
08809295141809	K221277	000
08809295141793	K221277	000
08809295141601	K221277	000
08809295141595	K221277	000
08809295141588	K221277	000
08809295141564	K221277	000
08809295141359	K221277	000
08809295141342	K221277	000
08809295147023	K221277	000
08809295148853	K221277	000
08809295148969	K221277	000
08809295148952	K221277	000
08809295148945	K221277	000
08809295148938	K221277	000
08809295148921	K221277	000
08809295148914	K221277	000
08809295148907	K221277	000
08809295148891	K221277	000
08809295148884	K221277	000
08809295148877	K221277	000
08809295148860	K221277	000
08809295141335	K221277	000