510(k) K073538

DUAL CHAMBER TPN CONTAINER by B.Braun Medical, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2008
Date Received
December 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type