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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 K895358
Device Name THERMO-5000
Applicant
Medtronix Ltd., Inc.
27 So. Broad St.
Commerce,  GA  30529
Applicant Contact SANDRA L BAINES
Correspondent
Medtronix Ltd., Inc.
27 So. Broad St.
Commerce,  GA  30529
Correspondent Contact SANDRA L BAINES
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received08/28/1989
Decision Date 05/07/1990
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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