FHC MICROTARGETING DRIVE SYSTEM

Neurological Stereotaxic Instrument

FHC, INC.

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

Pre-market Notification Details

Device IDK011992
510k NumberK011992
Device Name:FHC MICROTARGETING DRIVE SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant FHC, INC. 9 MAIN ST. Bowdoinham,  ME  04008
ContactFrederick Haer
CorrespondentFrederick Haer
FHC, INC. 9 MAIN ST. Bowdoinham,  ME  04008
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-26
Decision Date2001-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00873263006344 K011992 000

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