MICROTARGETING XL STAR DRIVE SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K121950
Device Name MICROTARGETING XL STAR DRIVE SYSTEM
Applicant
FHC, INC.
1201 main st
bowdoin, 
ME 
04287

Applicant Contact keri seitz
Correspondent
FHC, INC.
1201 main st
bowdoin, 
ME 
04287

Correspodent Contact keri seitz
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 07/03/2012
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