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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Temperature Measurement, Direct Contact, Powered
510(k) Number K894772
Device Name THERMALGRAPHIC ANALYSER
Applicant
MEDTECH INSTRUMENTS
7920 N.E. EVERETT
PORTLAND,  OR  97213
Applicant Contact JOHN MEGEHEE
Correspondent
MEDTECH INSTRUMENTS
7920 N.E. EVERETT
PORTLAND,  OR  97213
Correspondent Contact JOHN MEGEHEE
Regulation Number882.1570
Classification Product Code
HCS  
Date Received07/26/1989
Decision Date 10/03/1989
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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