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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 K122422
Models 50-7280, 50-9000B
Device Name PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
Original Applicant
CAREFUSION
1500 waukegan road
mcgaw park \,  IL  60085
Original Contact joy greidanus
Regulation Number876.5630
Classification Product Code
FJS  
Date Received08/09/2012
Decision Date 10/24/2012
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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