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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K233977
Device Name Velacur
Applicant
Sonic Incytes
#309-1788 West 5th Ave
Vancouver,  CA V6J1P2
Applicant Contact Tinuade Orimalade
Correspondent
Z & B Enterprises, Inc.
12154 Darnestown Road, #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/18/2023
Decision Date 09/04/2024
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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