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FDA 510(k) Application Details - K201099
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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510(K) Number
K201099
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact
Amy Honey
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
04/24/2020
Decision Date
08/12/2020
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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