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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, aneurysm
510(k) Number K211183
Device Name Sugita AVM Microclips
Applicant
Mizuho America, Inc.
30057 Ahern Avenue
Union City,  CA  94587
Applicant Contact Richard Chadwick
Correspondent
Mizuho America, Inc.
30057 Ahern Avenue
Union City,  CA  94587
Correspondent Contact Richard Chadwick
Regulation Number882.5200
Classification Product Code
HCH  
Date Received04/20/2021
Decision Date 03/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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