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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K210638
Device Name i-ED COIL System
Applicant
Kaneka Medical America LLC
623 Fifth Avenue
New York,  NY  10022
Applicant Contact Audra Bogucki
Correspondent
Kaneka Corporation
1-12-32, Akasaka
Minato-ku,  JP 107-6028
Correspondent Contact Takeaki Miyata
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received03/03/2021
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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