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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K781106
Device Name THERMOMETER, EXACTA TEMP
Applicant
S.M.B. Celsius Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
S.M.B. Celsius Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2920
Classification Product Code
FLK  
Date Received07/03/1978
Decision Date 08/10/1978
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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