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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 K030297
Device Name FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130
Applicant
Enraf-Nonius, B.V.
1. Rontgenweg
Delft,  NL NL-2624 BD
Applicant Contact RICK COELET
Correspondent
Enraf-Nonius, B.V.
1. Rontgenweg
Delft,  NL NL-2624 BD
Correspondent Contact RICK COELET
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/28/2003
Decision Date 04/28/2003
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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