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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 Delivery
510(k) Number K113272
Device Name INOMAX DS(DELIVERY SYSTEMS
Applicant
INO THERAPEUTICS LLC/DBA IKARIA
1060 Allendale Dr
Port Allen,  LA  70767
Applicant Contact LARRY LEPLEY
Correspondent
INO THERAPEUTICS LLC/DBA IKARIA
1060 Allendale Dr
Port Allen,  LA  70767
Correspondent Contact LARRY LEPLEY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MPQ   MRP  
Date Received11/04/2011
Decision Date 02/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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