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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K232435
Device Name Rhinolaryngoscope system
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
415, 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan
Community, Yuanshan Street, Longgang
Shenzhen,  CN 518100
Applicant Contact Cathy Shi
Correspondent
Shenzhen Chonconn Medical Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Yang Jie
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/14/2023
Decision Date 04/26/2024
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
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