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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K250462
Device Name UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
Applicant
Univlabs Technologies Private Limited
Plot No : 31, Sector -33, Near Info-City 2
Haryana
Gurugram,  IN 122003
Applicant Contact Sunil Kumar Singh
Correspondent
Univlabs Technologies Private Limited
Plot No : 31, Sector -33, Near Info-City 2
Haryana
Gurugram,  IN 122003
Correspondent Contact Vishwanath Pratap Singh
Regulation Number876.1500
Classification Product Code
FET  
Date Received02/18/2025
Decision Date 08/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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