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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 K091641
FOIA Releasable 510(k) K091641
Device Name HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
Applicant
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO,  CA  92656 -1408
Applicant Contact Naomi Gong
Correspondent
MICROVENTION, INC.
75 COLUMBIA
SUITE A
ALISO VIEJO,  CA  92656 -1408
Correspondent Contact Naomi Gong
Regulation Number882.5950
Classification Product Code
HCG  
Date Received06/04/2009
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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