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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 K792426
Device Name DISPOSABLE TEMPERATURE PROBE
Applicant
Hospitak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hospitak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2920
Classification Product Code
FLK  
Date Received11/28/1979
Decision Date 01/16/1980
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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