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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 K242513
Device Name FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
Applicant
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St.
Foshan,  CN 528200
Applicant Contact Weijuan Guo
Correspondent
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St.
Foshan,  CN 528200
Correspondent Contact Weijuan Guo
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
IZI  
Date Received08/23/2024
Decision Date 10/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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