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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
510(k) Number K821049
Device Name PARATHERM
Applicant
American Thermometer Company, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Thermometer Company, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.2982
Classification Product Code
KYA  
Date Received04/06/1982
Decision Date 04/29/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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