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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K251068
Device Name KnoxFog Anti-fogging Device
Applicant
Uv One Hygienics, Inc.
Banner Desert Hospital Medical Campus
1432 S. Dobson Rd., Suite 202
Mesa,  AZ  85202
Applicant Contact Dora Suppes
Correspondent
Uv One Hygienics, Inc.
Banner Desert Hospital Medical Campus
1432 S. Dobson Rd., Suite 202
Mesa,  AZ  85202
Correspondent Contact Dora Suppes
Regulation Number876.1500
Classification Product Code
OCT  
Date Received04/07/2025
Decision Date 08/27/2025
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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