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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Migraine/Tension Headache
510(k) Number K202523
Device Name TMJ Relax
Applicant
Moonwalker Innovations Inc
20 Roosevelt Rd
Medford,  MA  02155
Applicant Contact Charles Sutera
Correspondent
Moonwalker Innovations Inc
20 Roosevelt Rd
Medford,  MA  02155
Correspondent Contact Charles Sutera
Classification Product Code
OCO  
Date Received09/01/2020
Decision Date 06/24/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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