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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 Color Change
510(k) Number K772233
Device Name THERMOMETER RECAL ADAPTER
Applicant
Info-Chem
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Info-Chem
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received12/07/1977
Decision Date 12/20/1977
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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