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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthguard, prescription
510(k) Number K111066
Device Name MIGRA TAB, QUICKSPLINT MIGRAINE
Applicant
MIGRATHERAPY LLC
4403 MANCHESTER AVENUE,
SUITE 103
ENCINITAS,  CA  92024
Applicant Contact BRADLEY ELI
Correspondent
MIGRATHERAPY LLC
4403 MANCHESTER AVENUE,
SUITE 103
ENCINITAS,  CA  92024
Correspondent Contact BRADLEY ELI
Classification Product Code
MQC  
Date Received04/18/2011
Decision Date 11/22/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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