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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 K133951
Device Name SMARTTOUCH
Applicant
NEXUS6, LTD.
8 COMMERCE STREET
SUITE 205
AUCKLAND,  NZ 1010
Applicant Contact GARTH SUTHERLAND
Correspondent
NEXUS6, LTD.
8 COMMERCE STREET
SUITE 205
AUCKLAND,  NZ 1010
Correspondent Contact GARTH SUTHERLAND
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/23/2013
Decision Date 04/25/2014
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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