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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, suction, patient care
510(k) Number K121849
Model 50-7000B, 50-7280, 50-7260, TBD
Device Name PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
Original Applicant
CAREFUSION
1500 waukegan road
mcgaw park,  IL  60085
Original Contact joy greidanus
Regulation Number870.5050
Classification Product Code
DWM  
Date Received06/25/2012
Decision Date 10/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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