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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 K192068
Device Name i-ED COIL
Kaneka Pharma America LLC
546 Fifth Avenue
21st Floor
New York,  NY  10036
Applicant Contact Kazuhiko Inoue
Kaneka Corporation
1-12-32 Akasaka
Minato-ku,  JP 107-6028
Correspondent Contact Takeaki Miyata
Regulation Number882.5950
Classification Product Code
Subsequent Product Code
Date Received08/01/2019
Decision Date 04/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No