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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 K121365
Device Name THERMOFORMED MOUTHGUARDS
Applicant
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
2181 dupont dr.
irvine,  CA  92612
Contact armin zehtabchi
Classification Product Code
MQC  
Date Received05/07/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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