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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K230407
Device Name FloNavi Open Field Fluorescence Imaging System
Applicant
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St., Daxu, Guicheng, Nanhai,
Foshan,  CN 528200
Applicant Contact Alice Lau
Correspondent
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St., Daxu, Guicheng, Nanhai,
Foshan,  CN 528200
Correspondent Contact Alice Lau
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
GCJ   IZI  
Date Received02/15/2023
Decision Date 07/17/2023
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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