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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 K121021
Device Name INOMAX DS (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS
2902 DAIRY DRIVE
MADISON,  WI  53718
Applicant Contact DAVID TRUEBLOOD
Correspondent
INO THERAPEUTICS
2902 DAIRY DRIVE
MADISON,  WI  53718
Correspondent Contact DAVID TRUEBLOOD
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received04/04/2012
Decision Date 09/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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