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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
Predetermined Change
Control Plan Authorized		 No
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