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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K173111
Device Name LAP-iX Suction Irrigation
Applicant
Sejong Medical Co., Ltd.
11, Sinchon 2-Ro
Paju-Si,  KR 10880
Applicant Contact Yoojung Choi
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/29/2017
Decision Date 11/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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