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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, Non-Implanted
510(k) Number K192807
Device Name Duo-Flow Side x Side Double Lumen Catheter
Applicant
Medical Components Inc. (dba MedComp)
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medical Components Inc. (dba MedComp)
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number876.5540
Classification Product Code
MPB  
Date Received10/01/2019
Decision Date 04/23/2020
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
Predetermined Change
Control Plan Authorized		 No
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