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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, Backup Delivery
510(k) Number K122689
Device Name INOBLENDER
Applicant
Ino Therapeutics
2902 Dairy Dr.
Madison,  WI  53718
Applicant Contact ROBERT BOVY
Correspondent
Ino Therapeutics
2902 Dairy Dr.
Madison,  WI  53718
Correspondent Contact ROBERT BOVY
Regulation Number868.5165
Classification Product Code
MRO  
Date Received09/04/2012
Decision Date 11/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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