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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 K960037
Device Name SUGITA AVM MICROCLIP
Applicant
MIZUHO AMERICA, INC.
123 BRIMBAL AVE.
BEVERLY,  MA  01915
Applicant Contact LISA A SCHWEITZER
Correspondent
MIZUHO AMERICA, INC.
123 BRIMBAL AVE.
BEVERLY,  MA  01915
Correspondent Contact LISA A SCHWEITZER
Regulation Number882.5200
Classification Product Code
HCH  
Date Received01/03/1996
Decision Date 02/05/1997
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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