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FDA 510(k) Application Details - K171696
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K171696
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
Praxair Distribution, Inc
10 Riverview Drive
Danbury, CT 06810 US
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Contact
Michael E. Skrjanc
Other 510(k) Applications for this Contact
Regulation Number
868.5165
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Classification Product Code
MRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/07/2017
Decision Date
10/02/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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