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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, anti-snoring
510(k) Number K221889
Device Name ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
Applicant
ProSomnus Sleep Technologies
5860 W Las Positas Blvd.
Suite 25
Pleasanton,  CA  94588
Applicant Contact Divya Mavalli
Correspondent
ProSomnus Sleep Technologies
5860 W Las Positas Blvd.
Suite 25
Pleasanton,  CA  94588
Correspondent Contact Divya Mavalli
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/29/2022
Decision Date 10/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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