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FDA 510(k) Application Details - K121021
Device Classification Name
Apparatus, Nitric Oxide Delivery
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510(K) Number
K121021
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
INO THERAPEUTICS
2902 DAIRY DRIVE
MADISON, WI 53718 US
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DAVID TRUEBLOOD
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Regulation Number
868.5165
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Classification Product Code
MRN
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More FDA Info for this Product Code
Date Received
04/04/2012
Decision Date
09/24/2012
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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