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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K241500
Device Name Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave.
Guangzhou International Bioisland, Huangpu District
Guangzhou,  CN 510000
Applicant Contact Weihua Yang
Correspondent
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave.
Guangzhou International Bioisland, Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Xiaomin Lin
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received05/28/2024
Decision Date 07/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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