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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 K243867
Device Name LAGIS Suction Irrigation System
Applicant
Lagis Enterprise Co., Ltd.
# 29, Gong 1st Rd., Dajia Dist.
Taichung City,  TW 43762
Applicant Contact Lynn Chen
Correspondent
Lagis Enterprise Co., Ltd.
# 29, Gong 1st Rd., Dajia Dist.
Taichung City,  TW 43762
Correspondent Contact Lynn Chen
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/17/2024
Decision Date 03/17/2025
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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