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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, Bldg. 2, # 1, Mawu Rd., Baoan
Community, Yuanshan St., Longgang
Shenzhen,  CN 518100
Applicant Contact Cathy Shi
Correspondent
Shenzhen Chonconn Medical Consulting Co., Ltd.
Rm. 504, Block C
# 1029 Nanhai Ave., 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
Predetermined Change
Control Plan Authorized		 No
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