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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 K240003
Device Name Velmeni for Dentists (V4D)
Applicant
Velmeni Inc.
333 West Maude Avenue
Suite 207
Sunnyvale,  CA  94085
Applicant Contact Mini Suri
Correspondent
Velmeni Inc.
333 West Maude Avenue
Suite 207
Sunnyvale,  CA  94085
Correspondent Contact Mini Suri
Regulation Number892.2070
Classification Product Code
MYN  
Date Received01/02/2024
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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