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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 K232003
Device Name Endoscopic Video Image Processor, Single-Use Video Hysteroscope
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave.,
Guangzhou International Bioisland, Huangpu District
Guangzhou,  CN 510200
Applicant Contact Xiangfei Li
Correspondent
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave.,
Guangzhou International Bioisland, Huangpu District
Guangzhou,  CN 510200
Correspondent Contact Xiangfei Li
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/06/2023
Decision Date 02/12/2024
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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