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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical planning software for neurological stereotaxic instruments
510(k) Number K231141
Device Name STarFix Designer Software C0265
Applicant
FHC, Inc.
1201 Main Street
Bowdoin,  ME  04287
Applicant Contact Kelly Moeykens
Correspondent
FHC, Inc.
1201 Main Street
Bowdoin,  ME  04287
Correspondent Contact Kelly Moeykens
Regulation Number882.4560
Classification Product Code
QRI  
Subsequent Product Code
HAW  
Date Received04/21/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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