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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 K071095
Device Name ASPIRA PLEURAL DRAINAGE SYSTEM
Applicant
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact JIHYUN KIM
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact BRADLEY BONNETTE
Regulation Number870.5050
Classification Product Code
DWM  
Date Received04/18/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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