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FDA 510(k) Application Details - K150486
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
More FDA Info for this Device
510(K) Number
K150486
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
J & J Solutions, Inc. d/b/a/Corvida Medical
2261 Crosspark Road, Suite 127
Coralville, IA 52241 US
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Contact
Dana Schramm
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
ONB
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More FDA Info for this Product Code
Date Received
02/24/2015
Decision Date
07/24/2015
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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