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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 K010399
Device Name DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
Applicant
Diatek, Inc.
101 N. Chestnut St. #300
Winston-Salem,  NC  27101
Applicant Contact TODD CASSIDY
Correspondent
Diatek, Inc.
101 N. Chestnut St. #300
Winston-Salem,  NC  27101
Correspondent Contact TODD CASSIDY
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/09/2001
Decision Date 08/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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