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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 K061901
Device Name INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
Applicant
INO THERAPEUTICS
7601-B MURPHY DRIVE
MIDDLETON,  WI  53562
Applicant Contact FREDERICK MONTGOMERY
Correspondent
INO THERAPEUTICS
7601-B MURPHY DRIVE
MIDDLETON,  WI  53562
Correspondent Contact FREDERICK MONTGOMERY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received07/05/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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