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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 K101843
Device Name DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
Applicant
ANGIODYNAMICS, INC.
14 PLAZA DRIVE
LATHAM,  NY  12110
Applicant Contact DAVID A GREER
Correspondent
ANGIODYNAMICS, INC.
14 PLAZA DRIVE
LATHAM,  NY  12110
Correspondent Contact DAVID A GREER
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/01/2010
Decision Date 10/20/2010
Decision Substantially Equivalent - Kit (SESK)
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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