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FDA 510(k) Application Details - K172499
Device Classification Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
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510(K) Number
K172499
Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant
JMS North America Corporation
22320 Foothill Blvd. Suite 350
Hayward, CA 94541 US
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Contact
Sho Hosoki
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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
08/18/2017
Decision Date
06/01/2018
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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