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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleep Appliances With Patient Monitoring
510(k) Number K190353
Device Name Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Applicant
Residential Home Sleep Services
4602 Beckley Road
Battle Creek,  MI  49015 -7932
Applicant Contact Chris Gillette
Correspondent
Residential Home Sleep Services
4602 Beckley Road
Battle Creek,  MI  49015 -7932
Correspondent Contact Chris Gillette
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Code
LRK  
Date Received02/15/2019
Decision Date 04/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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