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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 K202499
Device Name Diamond Digital Sleep Orthotic (DDSO)
Applicant
Diamond Orthotic Laboratory
7859 El Cajon Blvd.
La Mesa,  CA  91942
Applicant Contact Matt Rago
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvurt
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/31/2020
Decision Date 09/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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