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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, peritoneal, long-term indwelling
510(k) Number K121383
Model MC20SC, MC20XS
Device Name PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number876.5630
Classification Product Code
FJS  
Date Received05/08/2012
Decision Date 09/05/2012
Decision substantially equivalent - kit (SK)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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