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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K972857
Device Name SERVOTRONIC EC100 SYSTEM
Applicant
MEDICON, E.G.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN
Correspondent
MEDICON, E.G.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number882.4360
Classification Product Code
HBC  
Date Received08/01/1997
Decision Date 01/16/1998
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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