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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 K173541
Device Name EPINAUT
Imedicom Co., Ltd.
#612, 172, LS-ro
Gunpo-si,  KR 435824
Applicant Contact Priscilla Chung
LK Consulting Group USA, Inc.
690 Roosevelt,
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number868.5120
Classification Product Code
Date Received11/15/2017
Decision Date 08/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No