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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, repair, catheter, hemodialysis
510(k) Number K020430
Device Name DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
Applicant
DIATEK, INC.
101 N. CHESTNUT ST. #300
WINSTON-SALEM,  NC  27101
Applicant Contact JON WILSON
Correspondent
DIATEK, INC.
101 N. CHESTNUT ST. #300
WINSTON-SALEM,  NC  27101
Correspondent Contact JON WILSON
Regulation Number876.5540
Classification Product Code
NFK  
Date Received02/08/2002
Decision Date 05/09/2002
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
Recalls CDRH Recalls
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