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FDA 510(k) Application Details - K041415
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K041415
Device Name
Container, I.V.
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
Other 510(k) Applications for this Company
Contact
AMY SMITH
Other 510(k) Applications for this Contact
Regulation Number
880.5025
More FDA Info for this Regulation Number
Classification Product Code
KPE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/27/2004
Decision Date
08/04/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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