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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Temperature Discrimination
510(k) Number K864345
Device Name NTE-2 THERMAL SENSITIVITY TESTER
Applicant
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Applicant Contact RONALD FELLER
Correspondent
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Correspondent Contact RONALD FELLER
Regulation Number882.1200
Classification Product Code
LQW  
Date Received11/04/1986
Decision Date 01/29/1987
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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