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FDA 510(k) Application Details - K211183
Device Classification Name
Clip, Aneurysm
More FDA Info for this Device
510(K) Number
K211183
Device Name
Clip, Aneurysm
Applicant
Mizuho America, Inc.
30057 Ahern Avenue
Union City, CA 94587 US
Other 510(k) Applications for this Company
Contact
Richard Chadwick
Other 510(k) Applications for this Contact
Regulation Number
882.5200
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Classification Product Code
HCH
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More FDA Info for this Product Code
Date Received
04/20/2021
Decision Date
03/02/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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