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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 K042297
Device Name ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
Applicant
ACTA VASCULAR SYSTEMS, INC.
247 MARCHMONT DR.
LOS GATOS,  CA  95032
Applicant Contact RICHARD M RUEDY
Correspondent
ACTA VASCULAR SYSTEMS, INC.
247 MARCHMONT DR.
LOS GATOS,  CA  95032
Correspondent Contact RICHARD M RUEDY
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received08/24/2004
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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