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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 K042672
Device Name 14F DUAL FLOATING DIALYSIS CATHETER/TRAY
Applicant
Cardio Med Supplies, Inc.
5 Gormley Industrial Ave.
Gormley, Ontario,  CA L0H 1G0
Applicant Contact CHRISTIAN G DUBE
Correspondent
Cardio Med Supplies, Inc.
5 Gormley Industrial Ave.
Gormley, Ontario,  CA L0H 1G0
Correspondent Contact CHRISTIAN G DUBE
Regulation Number876.5540
Classification Product Code
MSD  
Date Received09/29/2004
Decision Date 03/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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