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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 K203462
Device Name Advanced Dental Appliance
Applicant
DaSoft Partners
4079 Governor Drive #111
San Diego,  CA  92122
Applicant Contact Dante Togliatti
Correspondent
J Blane, LLC
980 N Sinagua Heights Dr
Flagstaff,  AZ  86004
Correspondent Contact Kimberly Lane
Regulation Number872.5570
Classification Product Code
LRK  
Date Received11/24/2020
Decision Date 02/19/2021
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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