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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, nitric oxide, backup delivery
510(k) Number K122689
Model 10004
Device Name INOBLENDER
Original Applicant
INO THERAPEUTICS
2902 dairy drive
madison,  WI  53718
Original Contact robert bovy
Regulation Number868.5165
Classification Product Code
MRO  
Date Received09/04/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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