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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K090958
Device Name INOMAX DS (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS LLC
2902 DAIRY DR.
MADISON,  WI  53718
Applicant Contact DAVID TRUEBLOOD
Correspondent
INO THERAPEUTICS LLC
2902 DAIRY DR.
MADISON,  WI  53718
Correspondent Contact DAVID TRUEBLOOD
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/06/2009
Decision Date 06/18/2009
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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