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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K830530
Device Name TEMP TRACE
Applicant
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/18/1983
Decision Date 04/06/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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