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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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