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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 K130889
Device Name SPLIT CATH RG
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
MSD  
Date Received03/29/2013
Decision Date 04/28/2014
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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