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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, Implanted, Coated
510(k) Number K112477
Device Name PALINDROME H, SI, HSI CHRONIC 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
NYU  
Subsequent Product Code
MSD  
Date Received08/29/2011
Decision Date 09/28/2011
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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