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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 K153010
Device Name Hudson RCI AquaPak Sterile Prefilled Nebulizers
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Brian Gall
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Brian Gall
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/14/2015
Decision Date 07/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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