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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peritoneal, long-term indwelling
510(k) Number K180485
Device Name Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
Applicant
Covidien, llc
15 Hampshire Street
Mansfield,  MA  02048
Applicant Contact Carol Ming
Correspondent
Covidien, llc
15 Hampshire Street
Mansfield,  MA  02048
Correspondent Contact Carol Ming
Regulation Number876.5630
Classification Product Code
FJS  
Subsequent Product Code
FKO  
Date Received02/23/2018
Decision Date 07/27/2018
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
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