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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 K110936
Device Name DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
Applicant
AngioDynamics, Inc.
14 Plaza Dr.
Latham,  NY  12110
Applicant Contact DAVID A GREER
Correspondent
AngioDynamics, Inc.
14 Plaza Dr.
Latham,  NY  12110
Correspondent Contact DAVID A GREER
Regulation Number876.5540
Classification Product Code
MSD  
Date Received04/04/2011
Decision Date 06/10/2011
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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