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FDA 510(k) Application Details - K141448
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
More FDA Info for this Device
510(K) Number
K141448
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
TEVA MEDICAL LTD., MIGADA PLANT
PIAZZA ALBANIA, 10
ROME 00153 IT
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Contact
ROGER L GRAY
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
ONB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2014
Decision Date
01/23/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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