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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K071939
Device Name HYDROCOIL EMBOLIC SYSTEMS (HES)
Applicant
MicroVention, Inc.
75 Columbia
Aliso Viejo,  CA  92656 -1408
Applicant Contact VINCENT CUTARELLI
Correspondent
MicroVention, Inc.
75 Columbia
Aliso Viejo,  CA  92656 -1408
Correspondent Contact VINCENT CUTARELLI
Regulation Number870.3300
Classification Product Code
KRD  
Date Received07/13/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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