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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 K060509
Device Name PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
Applicant
TYCO HEALTHCARE GROUP
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact KEITH MARTIN
Correspondent
TYCO HEALTHCARE GROUP
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact KEITH MARTIN
Regulation Number876.5540
Classification Product Code
NYU  
Date Received02/27/2006
Decision Date 06/23/2006
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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