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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 K231663
Device Name The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
Applicant
Innovative Health Technologies (Nz), Ltd.
229 Mopray Pl
Dunedin,  NZ 9016
Applicant Contact Chapman Philip
Correspondent
Innovative Health Technologies (Nz), Ltd.
229 Mopray Pl
Dunedin,  NZ 9016
Correspondent Contact Wonde Tekolla
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/07/2023
Decision Date 09/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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