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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 K092545
Device Name INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Applicant
Ino Therapeutics, LLC
2902 Dairy Dr.
Madison,  WI  53718
Applicant Contact LARRY LEPLEY
Correspondent
Ino Therapeutics, LLC
2902 Dairy Dr.
Madison,  WI  53718
Correspondent Contact LARRY LEPLEY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received08/19/2009
Decision Date 03/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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