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FDA 510(k) Application Details - K092545
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K092545
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
INO THERAPEUTICS LLC
2902 DAIRY DR.
MADISON, WI 53718 US
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Contact
LARRY LEPLEY
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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
08/19/2009
Decision Date
03/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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