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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 K253184
Device Name Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
Applicant
Zhuhai Wesee Meditech Co., Ltd.
3-301, 178 Dingxing Rd., Tangjiawan Town,
Hitech Zone
Zhuhai,  CN 519085
Applicant Contact Ruiliang Xie
Correspondent
Zhuhai Wesee Meditech Co., Ltd.
3-301, 178 Dingxing Rd., Tangjiawan Town,
Hitech Zone
Zhuhai,  CN 519085
Correspondent Contact Ruiliang Xie
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/26/2025
Decision Date 03/25/2026
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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