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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K842878
Device Name GST SYSTEM THERMOGRAPHIC APPLICATION
Applicant
Gst Laboratories of Ca, Inc.
Burditt, Bowles & Radzius
135 S. La Salle St.
Chicago,  IL  60603
Applicant Contact JOSEPH R RADZIUS
Correspondent
Gst Laboratories of Ca, Inc.
Burditt, Bowles & Radzius
135 S. La Salle St.
Chicago,  IL  60603
Correspondent Contact JOSEPH R RADZIUS
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received07/23/1984
Decision Date 03/22/1985
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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