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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, Triple Lumen, Non-Implanted
510(k) Number K020089
Device Name MAHURKAR TRIPLE LUMEN CATHETER, 12 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
NIE  
Date Received01/10/2002
Decision Date 04/10/2002
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
Recalls CDRH Recalls
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