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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 K080484
Device Name INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Applicant
INO THERAPEUTICS
6 ROUTE 173
CLINTON,  NJ  08809
Applicant Contact DAVID TRUEBLOOD
Correspondent
INO THERAPEUTICS
6 ROUTE 173
CLINTON,  NJ  08809
Correspondent Contact DAVID TRUEBLOOD
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received02/22/2008
Decision Date 08/06/2008
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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