MICROTARGETING GUIDELINE 4000

Device Classification Name

electrode, depth

510(k) Number K071364
Device Name MICROTARGETING GUIDELINE 4000
Applicant
FHC, INC.
1201 main st
bowdoin, 
ME 
04287

Applicant Contact lee d margolin
Regulation Number 882.1330
Classification Product Code
GZL  
Date Received 05/16/2007
Decision Date 07/25/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls