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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K180407
Device Name Smartinhaler
Applicant
Adherium (NZ) Ltd
Level 2, 204 Quay Street
Auckland,  NZ 1010
Applicant Contact Chris Mander
Correspondent
Adherium (NZ) Ltd
Level 2, 204 Quay Street
Auckland,  NZ 1010
Correspondent Contact Chris Mander
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/14/2018
Decision Date 07/25/2018
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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