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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
510(k) Number K123196
Device Name PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact JENNIFER SULLIVAN
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact JENNIFER SULLIVAN
Regulation Number876.5540
Classification Product Code
MSD  
Subsequent Product Code
NYU  
Date Received10/11/2012
Decision Date 01/31/2013
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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