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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 K152882
Device Name Propeller System
Applicant
RECIPROCAL LABS
634 W. MAIN STREET, SUITE 102
MADISON,  WI  53703
Applicant Contact DAVID HUBANKS
Correspondent
RECIPROCAL LABS
634 W. MAIN STREET, SUITE 102
MADISON,  WI  53703
Correspondent Contact DAVID HUBANKS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/2015
Decision Date 03/08/2016
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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