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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
Predetermined Change
Control Plan Authorized		 No
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