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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 K240978
Device Name SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
Applicant
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen,  CN
Applicant Contact Linbin Ye
Correspondent
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen,  CN
Correspondent Contact Linbin Ye
Regulation Number884.1690
Classification Product Code
HIH  
Date Received04/10/2024
Decision Date 08/16/2024
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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