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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, jaw repositioning
510(k) Number K233754
Device Name AIO Breathe
Aiomega, LLC
3187 Paluxy Drive
Tyler,  TX  75701
Applicant Contact Raghavendra Ghuge
Aiomega, LLC
3187 Paluxy Drive
Tyler,  TX  75701
Correspondent Contact Raghavendra Ghuge
Regulation Number872.5570
Classification Product Code
Subsequent Product Code
Date Received11/22/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No