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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 K111372
FOIA Releasable 510(k) K111372
Device Name TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact WING NG
Correspondent
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact WING NG
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/16/2011
Decision Date 08/04/2011
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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