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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 K113354
Device Name VETA PERITONEAL DIALYSIS CATHETER
Original Applicant
PFM MEDICAL, INC
1815 aston ave
suite 106
carlsbad,  CA  92008
Original Contact salvadore palomares
Regulation Number876.5630
Classification Product Code
FJS  
Date Received11/14/2011
Decision Date 03/13/2012
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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