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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K092192
Device Name WAYPOINT STEREOTACTIC SYSTEM
Applicant
FHC, INC.
1201 MAIN ST
BOWDOIN,  ME  04287
Applicant Contact LEE D MARGOLIN
Correspondent
FHC, INC.
1201 MAIN ST
BOWDOIN,  ME  04287
Correspondent Contact LEE D MARGOLIN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/21/2009
Decision Date 02/12/2010
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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