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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
Model MC101041P, MC101042P, MC101043P, MC101044P, MC101045P, MC101241P/ MC101242P, MC101243P, MC101244P, MC101245P
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 Received11/29/2011
Decision Date 03/09/2012
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No