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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 K965174
Device Name TRUFILL PVA PARTICLES
Applicant
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact JODI LYNN FRASIER
Correspondent
Cordis Neurovascular, Inc.
14740 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact JODI LYNN FRASIER
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/24/1996
Decision Date 03/21/1997
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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