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FDA 510(k) Application Details - K140591
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
More FDA Info for this Device
510(K) Number
K140591
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
MC237
FRANKLIN LAKES, NJ 07417-1885 US
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Contact
JOHN ROBERTS
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
ONB
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More FDA Info for this Product Code
Date Received
03/07/2014
Decision Date
05/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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