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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
Model 70-XX-XX
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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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