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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 W. 5th Ave.
Vancouver,  CA V6J1P2
Applicant Contact Tinuade Orimalade
Correspondent
Z&B Enterprises, Inc.
12154 Darnestown Rd., #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
Predetermined Change
Control Plan Authorized		 No
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