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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 K111474
Device Name BINGO PRO
Applicant
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
1 PLATIN ST.
NEW INDUSTRIAL ZONE
RISHON LEZION,  IL 75653
Applicant Contact YULIYA YUTKEVICH
Correspondent
FORUM ENGINEERING TECHNOLOGIES (96) LTD.
1 PLATIN ST.
NEW INDUSTRIAL ZONE
RISHON LEZION,  IL 75653
Correspondent Contact YULIYA YUTKEVICH
Classification Product Code
LQY  
Date Received05/27/2011
Decision Date 11/02/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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