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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
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