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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 K134015
Device Name M-PM-DISC
Applicant
MERZ DENTAL GMBH
5616 MARIOLA PL NE
ALBUQUERQUE,  NM  87111
Applicant Contact RICHARD G HUNTER
Correspondent
MERZ DENTAL GMBH
5616 MARIOLA PL NE
ALBUQUERQUE,  NM  87111
Correspondent Contact RICHARD G HUNTER
Classification Product Code
MQC  
Date Received12/27/2013
Decision Date 04/11/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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