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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 K964851
Device Name ENTRACARE THERMOMTER MODEL 1000
Applicant
Entracare Corp.
14400 College Blvd., Suite 101
Lenexa,  KS  66215
Applicant Contact AL BOEDEKER
Correspondent
Entracare Corp.
14400 College Blvd., Suite 101
Lenexa,  KS  66215
Correspondent Contact AL BOEDEKER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/03/1996
Decision Date 02/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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