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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultraviolet Radiation Disinfection Chamber Device
510(k) Number K251354
Device Name UV Smart D60
Applicant
UV Smart Technologies B.V.
Patrijsweg 74
Rijswijk,  NL 2289EX
Applicant Contact Thijs Kea
Correspondent
UV Smart Technologies B.V.
Patrijsweg 74
Rijswijk,  NL 2289EX
Correspondent Contact Thijs Kea
Classification Product Code
SCS  
Date Received04/30/2025
Decision Date 01/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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