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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K210270
Device Name Medical Endoscope Image Processing System
Applicant
Jiangsu Jiyuan Medical Technology Co., Ltd.
#48 Cecep (Taizhou) Environmental Protection Technology
Industry Park, # 59 Meilan Rd. Hai
Jiangsu,  CN 225300
Applicant Contact Zong Yunfeng
Correspondent
Microkn Business Consulting (Shanghai) Co., Ltd.
Rm. 1219, Block A, No 3699, Gonghexin Rd., Jingan District
Shanghai,  CN 200435
Correspondent Contact Yuling Chen
Regulation Number884.1690
Classification Product Code
HIH  
Date Received02/01/2021
Decision Date 10/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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