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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 K161454
Device Name Propeller Sensor Model 2015-E
Applicant
Reciprocal Labs Corporation
634 W. Main St., Suite 102
Madison,  WI  53703
Applicant Contact Taylor Mahan-Rudolph
Correspondent
Reciprocal Labs Corporation
634 W. Main St., Suite 102
Madison,  WI  53703
Correspondent Contact Taylor Mahan-Rudolph
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/26/2016
Decision Date 11/01/2016
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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