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510(k) K071095

ASPIRA PLEURAL DRAINAGE SYSTEM by Bard Access Systems, Inc. — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2007
Date Received
April 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

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