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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 K032619
Device Name MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Applicant
Surgica Corp.
5090 Robert J. Mathews Pkwy.
#4
El Dorado Hills,  CA  95762
Applicant Contact LOU MATSON
Correspondent
Surgica Corp.
5090 Robert J. Mathews Pkwy.
#4
El Dorado Hills,  CA  95762
Correspondent Contact LOU MATSON
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/26/2003
Decision Date 02/13/2004
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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