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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, hemodialysis, non-implanted
510(k) Number K122091
Model C-HDCS[Y]
Device Name COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
Original Applicant
COOK, INC.
750 daniels way
blmgtn,  IN  47404
Original Contact sean spence
Regulation Number876.5540
Classification Product Code
MPB  
Date Received07/16/2012
Decision Date 07/29/2013
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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