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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 K240196
Device Name Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
Applicant
Yuwonmeditech Co., Ltd.
Rm.103, 104, 108, 113, 114, 117, Donghwa Medical Instrument
147-1, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 26365
Applicant Contact Ji Hyeon Bae
Correspondent
Yuwonmeditech Co., Ltd.
Rm.103, 104, 108, 113, 114, 117, Donghwa Medical Instrument
147-1, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 26365
Correspondent Contact Ji Hyeon Bae
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/25/2024
Decision Date 06/18/2024
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
Predetermined Change
Control Plan Authorized		 No
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