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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 K022662
Device Name DIATEK CANNON-CATHETER, MODEL CC5500
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact THOMAS NICKEL
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact THOMAS NICKEL
Regulation Number876.5540
Classification Product Code
MSD  
Date Received08/09/2002
Decision Date 05/09/2003
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
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