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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 K033779
Device Name VIANOX DELIVERY SYSTEM, MODEL II
Applicant
Pulmonox Medical, Inc.
10835-120 St.
Suite 200
Edmonton, Ab,  CA T5H 3P9
Applicant Contact PAULA TOMAT
Correspondent
Pulmonox Medical, Inc.
10835-120 St.
Suite 200
Edmonton, Ab,  CA T5H 3P9
Correspondent Contact PAULA TOMAT
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received12/04/2003
Decision Date 01/26/2004
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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