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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 K160123
Device Name Apinator
Applicant
Allen J. Moses, Dds, Ltd.
233 S. Wacker Dr.
Chicago,  IL  60606
Applicant Contact Allen J Moses
Correspondent
Allen J. Moses, Dds, Ltd.
233 S. Wacker Dr.
Chicago,  IL  60606
Correspondent Contact Gloria Pacini
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/20/2016
Decision Date 07/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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