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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode/Lead, Electroencephalograph
510(k) Number K854396
Device Name RUB E-Z
Applicant
E-Z Instruments Co.
P.O. Box 680263
San Antonio,  TX  78268
Applicant Contact KENNETH R HARTMAN
Correspondent
E-Z Instruments Co.
P.O. Box 680263
San Antonio,  TX  78268
Correspondent Contact KENNETH R HARTMAN
Regulation Number882.1410
Classification Product Code
GYA  
Date Received10/31/1985
Decision Date 05/08/1986
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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