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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 K121950
Device Name MICROTARGETING XL STAR DRIVE SYSTEM
Original Applicant
FHC, INC.
1201 main st
bowdoin,  ME  04287
Original Contact keri seitz
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/03/2012
Decision Date 07/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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