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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 K121206
Device Name DETECT
Applicant
FORUM ENGINEERING TECHNOLOGIES LTD
1 PLATIN ST, NEW INDUSTRIAL ZONE
RISHON LEZION,  IL 75653
Applicant Contact YULIYA YUKEVICH
Correspondent
FORUM ENGINEERING TECHNOLOGIES LTD
1 PLATIN ST, NEW INDUSTRIAL ZONE
RISHON LEZION,  IL 75653
Correspondent Contact YULIYA YUKEVICH
Classification Product Code
LQY  
Date Received04/20/2012
Decision Date 01/10/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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