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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
510(k) Number K191728
Device Name ULTepap Expiratory Positive Airway Pressure (EPAP) Device
Applicant
Bryggs Medical, LLC
34910 Commerce Way
Avon,  OH  44011
Applicant Contact Geoffrey Sleeper
Correspondent
Bryggs Medical, LLC
34910 Commerce Way
Avon,  OH  44011
Correspondent Contact Geoffrey Sleeper
Regulation Number872.5570
Classification Product Code
OHP  
Date Received06/27/2019
Decision Date 02/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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