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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 K221861
Device Name FloNavi Endoscopic Fluorescence Imaging System
Applicant
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, #2 Yonganbei St.
Foshan,  CN 528200
Applicant Contact Jane Guo
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square, Nanshan
District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/27/2022
Decision Date 02/18/2023
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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