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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 K200638
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.
1150 Roosevelt STE 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/10/2020
Decision Date 04/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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