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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K233779
Device Name LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
Applicant
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.,
Guangming
Shenzhen,  CN 518107
Applicant Contact Linbin Ye
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C
# 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/27/2023
Decision Date 04/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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