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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
Applicant
Kaneka Pharma America LLC
546 Fifth Avenue
21st Floor
New York,  NY  10036
Applicant Contact Kazuhiko Inoue
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 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
Predetermined Change
Control Plan Authorized		 No
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