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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Aneurysm Clip
510(k) Number K221524
Device Name Sugita AVM Microclip Applier
Applicant
Mizuho America, Inc.
30057 Ahern Ave.
Union City,  CA  94587
Applicant Contact Richard Chadwick
Correspondent
Mizuho America, Inc.
30057 Ahern Ave.
Union City,  CA  94587
Correspondent Contact Richard Chadwick
Regulation Number882.4175
Classification Product Code
HCI  
Date Received05/26/2022
Decision Date 06/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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