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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 K190687
Device Name Twilite Appliance
Stephen J Harkins, DDS, PC
4781 E. Camp Lowell Dr., #101
Tucson,  AZ  85712
Applicant Contact Stephen Harkins
Stephen J Harkins, DDS, PC c/o ProMedic, LLC
131 Bay Point Dr NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
Date Received03/18/2019
Decision Date 07/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No