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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 K170985
Device Name Urbanek Device
Applicant
TMJ Services, LLC
2009 Mallory Lane
Franklin,  TN  37067
Applicant Contact Anthony Urbanek
Correspondent
MRC-X, LLC
6075 Poplar Ave; Suite 500
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received04/03/2017
Decision Date 09/25/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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