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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 K221781
Device Name Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
Applicant
Guangdong OptoMedic Technologies, Inc.
Suite 503, Building A, Golden Valley
Intellicreation Community, No. 2 Yonganbei Street
Foshan,  CN 528200
Applicant Contact Jane Guo
Correspondent
Guangdong OptoMedic Technologies, Inc.
Suite 503, Building A, Golden Valley
Intellicreation Community, No. 2 Yonganbei Street
Foshan,  CN 528200
Correspondent Contact Jane Guo
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/21/2022
Decision Date 02/02/2023
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
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