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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 K951314
Device Name TRUEFILL PVA PARTICLES
Applicant
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact MARLENE W VALENTI
Correspondent
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact MARLENE W VALENTI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/23/1995
Decision Date 08/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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