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FDA 510(k) Application Details - K210638
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K210638
Device Name
Device, Neurovascular Embolization
Applicant
Kaneka Medical America LLC
623 Fifth Avenue
New York, NY 10022 US
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Contact
Audra Bogucki
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
HCG
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More FDA Info for this Product Code
Date Received
03/03/2021
Decision Date
03/26/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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