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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K903402
Device Name GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L
Applicant
Medi-Source, Inc.
7719 State Rte. 656
Sunbury,  OH  43074
Applicant Contact BRUCE MACFARLANE
Correspondent
Medi-Source, Inc.
7719 State Rte. 656
Sunbury,  OH  43074
Correspondent Contact BRUCE MACFARLANE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/31/1990
Decision Date 08/22/1990
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
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