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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pillow, Cervical (For Mild Sleep Apnea)
510(k) Number K180608
Device Name Lunoa System
Applicant
Nightbalance BV
Benoordenhoustseweg 46-13
Den Haag,  NL
Applicant Contact Sophia Lam
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact Cindy Domecus, R.A.C. (US & EU)
Regulation Number872.5570
Classification Product Code
MYB  
Date Received03/07/2018
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01535521
NCT02045576
NCT02114424
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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