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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 K991522
Device Name MICROTARGETING 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 Received05/03/1999
Decision Date 08/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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