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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
Applicant
Imedicom Co., Ltd.
#612, 172, Ls-Ro
Gunpo-Si,  KR 435824
Applicant Contact Priscilla Chung
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number868.5120
Classification Product Code
BSO  
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
Predetermined Change
Control Plan Authorized		 No
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