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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, Triple Lumen, Non-Implanted
510(k) Number K181175
Device Name 12F Tri-Flow Triple Lumen Catheter
Applicant
Medical Components, Inc. (dba MedComp)
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medical Components, Inc. (dba MedComp)
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number876.5540
Classification Product Code
NIE  
Date Received05/02/2018
Decision Date 07/05/2018
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
Predetermined Change
Control Plan Authorized		 No
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