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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 K003776
Device Name MICROTARGETING DRIVE SYSTEM
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 Number882.4560
Classification Product Code
HAW  
Date Received12/07/2000
Decision Date 02/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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