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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurological stereotaxic instrument
510(k) Number K052840
Device Name IGI-SYSTEM
Applicant
DENX ADVANCED DENTAL SYSTEMS
MOSHAV ORA 106
JERUSALEM, AL,  IL 90880
Applicant Contact RACHEL WEISSBROD
Correspondent
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/07/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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