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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 K030165
Device Name THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
Applicant
Thermatrek
660 Main St., S., #7
Woodbury,  CT  06798
Applicant Contact DAVID R BALZER
Correspondent
Thermatrek
660 Main St., S., #7
Woodbury,  CT  06798
Correspondent Contact DAVID R BALZER
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received01/16/2003
Decision Date 04/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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