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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 K070867
Device Name INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Applicant
Ino Therapeutics, LLC
6 Route 173
Clinton,  NJ  08809
Applicant Contact RICHARD K BOURNE
Correspondent
Ino Therapeutics, LLC
6 Route 173
Clinton,  NJ  08809
Correspondent Contact RICHARD K BOURNE
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received03/29/2007
Decision Date 04/27/2007
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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