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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 K852454
Device Name CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
Applicant
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro, Inc.
600 Knightsbridge Pkwy.
Lincolnshire,  IL  60069
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/10/1985
Decision Date 08/16/1985
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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