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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 K802607
Device Name TERPERATUR SENSING DEVICE
Applicant
BURDITT & CALKINS-SIEMENS-ELEMA
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BURDITT & CALKINS-SIEMENS-ELEMA
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/21/1980
Decision Date 11/19/1980
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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