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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
Device Name COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact SEAN SPENCE
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact SEAN SPENCE
Regulation Number876.5540
Classification Product Code
MPB  
Date Received07/16/2012
Decision Date 07/29/2013
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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