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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 K202651
Device Name NOA Sleep Apnea and Snoring Device
Applicant
Orthoapnea S.L.
C / Flauta Magica 22
Malaga,  ES 29006
Applicant Contact Jose Repolles Llecha
Correspondent
Orthoapnea S.L.
C / Flauta Magica 22
Malaga,  ES 29006
Correspondent Contact Jose Repolles Llecha
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/14/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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