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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
Recalls CDRH Recalls
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