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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 K851224
Device Name WEST BEND ELECTRIC THERMOMETER
Applicant
The West Bend Co.
West Bend,  WI  53095
Applicant Contact HACKNEY
Correspondent
The West Bend Co.
West Bend,  WI  53095
Correspondent Contact HACKNEY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/26/1985
Decision Date 04/29/1985
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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