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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 K041914
Device Name PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
Applicant
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact JIM WELSH
Correspondent
Kendall
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact JIM WELSH
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/16/2004
Decision Date 09/27/2004
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
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