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FDA 510(k) Application Details - K170110
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
More FDA Info for this Device
510(K) Number
K170110
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
ICU MEDICAL INC
951 CALLE AMANECER
SAN CLEMENTE, CA 92673 US
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Contact
Jason Ma
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
01/12/2017
Decision Date
08/10/2018
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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