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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K033173
Device Name MICRO TARGETING ELECTRODE
Applicant
FHC, Inc.
9 Main St.
Bowdoinham,  ME  04008
Applicant Contact FREDERICK HAER
Correspondent
FHC, Inc.
9 Main St.
Bowdoinham,  ME  04008
Correspondent Contact FREDERICK HAER
Regulation Number882.1330
Classification Product Code
GZL  
Date Received10/01/2003
Decision Date 03/24/2004
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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