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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K870567
Device Name EVOPORT 300
Applicant
Dantec Electronics, Inc.
6 Pearl Court
Allendale,  NJ  07401
Applicant Contact HENRIK HENRIKSEN
Correspondent
Dantec Electronics, Inc.
6 Pearl Court
Allendale,  NJ  07401
Correspondent Contact HENRIK HENRIKSEN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/10/1987
Decision Date 10/06/1987
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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