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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 K001678
Device Name 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 Received06/01/2000
Decision Date 01/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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