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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 K113487
Device Name HEMO-CATH 10F, HEMO-CATH 12.5F
Original Applicant
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number876.5540
Classification Product Code
Date Received11/23/2011
Decision Date 03/09/2012
Decision substantially equivalent - kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No