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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 K192724
Device Name Propeller Sensor for Symbicort
Applicant
Reciprocal Labs Corporation
1 S. Pinckney St. Suite 610
Madison,  WI  53703
Applicant Contact Greg Dunkelberger
Correspondent
Reciprocal Labs Corporation
1 S. Pinckney St. Suite 610
Madison,  WI  53703
Correspondent Contact Greg Dunkelberger
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/27/2019
Decision Date 03/26/2020
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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