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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K070656
Device Name HYDROCOIL EMBOLIC SYSTEM (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 Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received03/09/2007
Decision Date 06/15/2007
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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