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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 K123292
Device Name T3
Applicant
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact TIMOTHY HOLWICK
Correspondent
Medcomp
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact TIMOTHY HOLWICK
Regulation Number876.5540
Classification Product Code
NIE  
Date Received10/22/2012
Decision Date 06/11/2013
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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