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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K250753
Device Name VELMENI for DENTISTS (V4D)
Applicant
Velmeni Inc.
333 West Maude Avenue , STE 207
Sunnyvale,  CA  94085
Applicant Contact Ishveen Anand
Correspondent
Velmeni Inc.
333 West Maude Avenue , STE 207
Sunnyvale,  CA  94085
Correspondent Contact Ishveen Anand
Regulation Number892.2070
Classification Product Code
MYN  
Date Received03/12/2025
Decision Date 09/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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