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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 K942461
Device Name NEUROLOGY ACCESSORIES - MARK-EASY 10-20
Applicant
Optimit USA, Inc.
8522 E. Helen Pl.
Tucson,  AZ  85715
Applicant Contact MARNI C PATTERSON
Correspondent
Optimit USA, Inc.
8522 E. Helen Pl.
Tucson,  AZ  85715
Correspondent Contact MARNI C PATTERSON
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/24/1994
Decision Date 10/19/1994
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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