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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K241410
Device Name EDEN ControlCath
Applicant
Jmt Co., Ltd.
70-39, Gwonyul-Ro 1203beon-Gil, Baekseok-Eup
Yangju-Si,  KR 11517
Applicant Contact Sang-Ok Nam
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number868.5120
Classification Product Code
BSO  
Date Received05/17/2024
Decision Date 02/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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