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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 K143671
Device Name Propeller Model 2014-D Sensor
Applicant
Reciprocal Labs
634 W. Main St., Suite 102
Madison,  WI  53703
Applicant Contact David Hubanks
Correspondent
Reciprocal Labs
634 W. Main St., Suite 102
Madison,  WI  53703
Correspondent Contact David Hubanks
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/23/2014
Decision Date 06/19/2015
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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