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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 K241987
Device Name Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Applicant Contact Weihua Yang
Correspondent
Guangzhou Red Pine Medical Instrument Co., Ltd.
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Guangzhou,  CN 510000
Correspondent Contact Ping Yang
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/08/2024
Decision Date 08/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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