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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 K100454
Device Name HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact LARAINE PANGELINA
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact LARAINE PANGELINA
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received02/17/2010
Decision Date 04/22/2010
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
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