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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 Street, Suite 102
Madison,  WI  53703
Applicant Contact Taylor Mahan-Rudolph
Correspondent
Reciprocal Labs Corporation
634 W. Main Street, 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
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