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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
Device Name PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
Applicant
CAREFUSION
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact JOY GREIDANUS
Correspondent
CAREFUSION
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact JOY GREIDANUS
Regulation Number870.5050
Classification Product Code
DWM  
Date Received06/25/2012
Decision Date 10/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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