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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 K110409
Device Name ASPIRA PLEURAL DRAINAGE SYSTEM
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact HENRY BOLAND
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact HENRY BOLAND
Regulation Number870.5050
Classification Product Code
DWM  
Date Received02/14/2011
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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