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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 K040315
Device Name MYOHEALTH CLENCHING INHIBITOR
Applicant
Mci-Myohealth Systems
26552 Tampico Place
Mission Viejo,  CA  92691
Applicant Contact DAVID BALDING
Correspondent
Mci-Myohealth Systems
26552 Tampico Place
Mission Viejo,  CA  92691
Correspondent Contact DAVID BALDING
Classification Product Code
MQC  
Date Received02/09/2004
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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