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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, Non-Implanted
510(k) Number K030209
Device Name MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
Applicant
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact REGINA YEH
Correspondent
THE KENDALL COMPANY
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact REGINA YEH
Regulation Number876.5540
Classification Product Code
MPB  
Date Received01/21/2003
Decision Date 05/13/2003
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
Recalls CDRH Recalls
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