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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 K022735
Device Name MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
Applicant
MICROVENTION, INC.
72 ARGONAUT
ALISO VIEJO,  CA  92656 -1408
Applicant Contact VINCENT CUTAURELLI
Correspondent
MICROVENTION, INC.
72 ARGONAUT
ALISO VIEJO,  CA  92656 -1408
Correspondent Contact VINCENT CUTAURELLI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/19/2002
Decision Date 09/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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