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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 K081691
Device Name INOMAX DS (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS LLC
2820 WALTON COMMONS WEST
MADISON,  WI  53718
Applicant Contact DAVID TRUEBLOOD
Correspondent
INO THERAPEUTICS LLC
2820 WALTON COMMONS WEST
MADISON,  WI  53718
Correspondent Contact DAVID TRUEBLOOD
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received06/17/2008
Decision Date 08/28/2008
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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