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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 K231725
Device Name Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
Applicant
Hunan Endoso Life Technology Co., Ltd.
4th Floor, Bldg. 10, Innovation And Entrepreneurship
Center, 31 Dongfeng Rd., Heping St., Xiangtan Economic D
Hunan,  CN 411199
Applicant Contact Fu Wang
Correspondent
Hunan Endoso Life Technology Co., Ltd.
4th Floor, Bldg. 10, Innovation And Entrepreneurship
Center, 31 Dongfeng Rd., Heping St., Xiangtan Economic D
Hunan,  CN 411199
Correspondent Contact Fu Wang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/13/2023
Decision Date 10/16/2023
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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