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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 K990202
Device Name SUGITA TITANIUM ANEURYSM CLIP
Applicant
Mizuho America, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact T.WHIT ATHEY
Correspondent
Mizuho America, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact T.WHIT ATHEY
Regulation Number882.5200
Classification Product Code
HCH  
Date Received01/21/1999
Decision Date 06/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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