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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 K171618
Device Name Symetrex Long Term Hemodialysis Catheter
Applicant
Medcomp (DBA Medical Components, Inc.)
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medcomp (DBA Medical Components, Inc.)
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number876.5540
Classification Product Code
MSD  
Date Received06/02/2017
Decision Date 11/16/2017
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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