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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 K073419
Device Name PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
Applicant
Rj Medical, Inc.
4921 Robert J. Mathews Pkwy.
#2
El Dorado Hills,  CA  95762
Applicant Contact JIM INNES
Correspondent
Rj Medical, Inc.
4921 Robert J. Mathews Pkwy.
#2
El Dorado Hills,  CA  95762
Correspondent Contact JIM INNES
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/05/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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