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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 K051584
Device Name 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact JAMES WELSH
Correspondent
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact JAMES WELSH
Regulation Number876.5540
Classification Product Code
MSD  
Date Received06/15/2005
Decision Date 10/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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