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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 K220567
Device Name Easi-Vue embolic microspheres System
Applicant
ABK Biomedical Inc
155 Chain Lake Drive
Unit 32
Halifax,  CA B3S 1B3
Applicant Contact Brandi Woods
Correspondent
ABK Biomedical Inc
155 Chain Lake Drive
Unit 32
Halifax,  CA B3S 1B3
Correspondent Contact Brandi Woods
Regulation Number870.3300
Classification Product Code
KRD  
Date Received02/28/2022
Decision Date 09/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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