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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K171726
Device Name LapBag
Sejong Medical Co., Ltd.
11, Sinchon 2-ro
Paju-si,  KR 10880
Applicant Contact Yoojung Choi
LK Consulting Group USA, Inc.
690 Roosevelt
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number876.1500
Classification Product Code
Date Received06/12/2017
Decision Date 09/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No