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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 K160531
Device Name Noiselezz
Applicant
Firma Ingemarsson
Vilvordevej 61
Charlottenlund,  DK 2920
Applicant Contact Natashia Ingemarsson-Matzen
Correspondent
Danish Medical Devices Consulting Aps
Doktor Mundtsvej 9b
Farum,  DK 3520
Correspondent Contact Poul Schmidt-Andersen
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/25/2016
Decision Date 09/01/2016
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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