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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K133130
Device Name BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
Applicant
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Applicant Contact DAVID E CHADWICK, PHD., RAC
Correspondent
COOK, INC.
750 DANIELS WAY
Blmgtn,  IN  47404
Correspondent Contact DAVID E CHADWICK, PHD., RAC
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/30/2013
Decision Date 01/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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