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510(k) K210638

i-ED COIL System by Kaneka Medical America, LLC — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
March 3, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

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