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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K151506
Device Name Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
Applicant
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Applicant Contact Mara Caler
Correspondent
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Correspondent Contact Mara Caler
Regulation Number868.5905
Classification Product Code
NFB  
Date Received06/04/2015
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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