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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K971306
Device Name FG INFUSION CATHETER
Applicant
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact Lisa Wells
Correspondent
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact Lisa Wells
Regulation Number870.1210
Classification Product Code
KRA  
Date Received04/08/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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