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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K234123
Device Name Easi-Vue® embolic microspheres System
Applicant
Abk Biomedical, Inc.
155 Chain Lake Dr.
Unit 32
Halifax,  CA B3S 1B3
Applicant Contact Brandi Woods
Correspondent
Abk Biomedical, Inc.
155 Chain Lake Dr.
Unit 32
Halifax,  CA B3S 1B3
Correspondent Contact Brandi Woods
Regulation Number870.3300
Classification Product Code
KRD  
Date Received12/28/2023
Decision Date 02/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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