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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 K832989
Device Name BREAST THERMAL ACTIVITY INDICATOR
Applicant
Bcsi Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bcsi Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.2982
Classification Product Code
KYA  
Date Received09/01/1983
Decision Date 01/17/1984
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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