MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

Neurological Stereotaxic Instrument

FHC, INC.

The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Microtargeting Star Drive System, Components.

Pre-market Notification Details

Device IDK092562
510k NumberK092562
Device Name:MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
ClassificationNeurological Stereotaxic Instrument
Applicant FHC, INC. 1201 MAIN ST Bowdoin,  ME  04287
ContactLee D Margolin
CorrespondentLee D Margolin
FHC, INC. 1201 MAIN ST Bowdoin,  ME  04287
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-20
Decision Date2009-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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