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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 K120674
Device Name MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact WING NG
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact WING NG
Regulation Number876.5540
Classification Product Code
MPB  
Subsequent Product Code
NIE  
Date Received03/05/2012
Decision Date 04/04/2012
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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