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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name locator, root apex
510(k) Number K103123
Device Name APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
Applicant
MICRO-MEGA SOCIETE ANONYME
5-12 RUE DU TUNNEL
CEDEX BESANCON,  FR 25006
Applicant Contact CONCHE PHILIPPE
Correspondent
MICRO-MEGA SOCIETE ANONYME
5-12 RUE DU TUNNEL
CEDEX BESANCON,  FR 25006
Correspondent Contact CONCHE PHILIPPE
Classification Product Code
LQY  
Date Received10/21/2010
Decision Date 03/10/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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